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Search Results Within Category "Diabetes & Endocrine"

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25 Study Matches

An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety,and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients with Central (Gonadotropin-Dependent) Precocious Puberty

The study drug FP-001 (Leuprolide mesylate) is being developed for children that are suffering from central (gonadotropin-dependent) precocious puberty (CPP). Leuprolide has been approved in the United States (US) and the European Union (EU) as treatment for prostate cancer already, and other forms of Leuprolide from other companies have been approved for the treatment of CPP. In this clinical study, Leuprolide will be used in the form of a 6-month depot injection.

Brad Miller, MD, PhD
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001817
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Inclusion Criteria:

• females aged 2 to 8 years or males aged 2 to 9 years old
• diagnosis of Central Precocious Puberty (CPP) within 12 months
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• major medical or psychiatric illness that could interfere with study visits
• history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
• specific prior treatments (study staff will review)
Children's Health, Diabetes & Endocrine
Central Precocious Puberty, CPP, Early Puberty, Precocious Puberty, Puberty

Efficacy and safety of SGLT2 inhibitor therapy in overweight and obese subjects with cystic fibrosis-related diabetes: a pilot study

In this study, we will examine the safety and tolerability of Sodium glucose co-transporter 2 inhibitor (SGLT2i) (generic name: empagliflozin) for patients who are overweight/obese and have been diagnosed with Cystic Fibrosis Related Diabetes (CFRD).

Amir Moheet
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019241
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Inclusion Criteria:

• 18 years or older
• diagnosis of cystic fibrosis related diabetes (CFRD)
• BMI >25 kg/m2
• woman who could become pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study
Exclusion Criteria:

• acute respiratory exacerbation requiring IV antibiotics or systemic glucocorticoids within prior 4 weeks
• less than 12 weeks since start of a new CFTR corrector/modulator therapy
• type 1 diabetes
• history of diabetic ketoacidosis
• history of recurrent genital or urinary tract infections
• women who are pregnant or breastfeeding
• history of eating disorder
• there are additional exclusion criteria (study staff will review)
Rare Diseases, Diabetes & Endocrine
CF, CFRD, Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Diabetes
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Atherosclerosis Risk in Communities (ARIC) Study - Visits Component (Le-Na)

The purpose of the Atherosclerosis Risk in Communities (ARIC) Study - ARIC Generation 2 research study is to evaluate the link between glucose and heart problems in adults with type 2 diabetes. Heart problems can be common in people with type 2 diabetes. We are interested in measuring your blood sugar (glucose) using a continuous glucose monitor and monitoring your heart rhythm at the same time.

Pamela Lutsey
18 years and over
This study is NOT accepting healthy volunteers
SITE00001721
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Inclusion Criteria:

• Have a diagnosis of Type II Diabetes
• Age 50-80 years old
• Be willing to wear a continuous glucose monitor and heart rhythm monitor for two weeks
• Fluent English speaker
Exclusion Criteria:

• Pacemaker
• Allergy to adhesive tape
• Planning to move away from the Minneapolis area in the next four years
• Live in nursing home/long-term care facility
• diagnosed with dementia or unable to consent for self
Diabetes & Endocrine, Heart & Vascular
aging, cognition, heart disease, Type 2 Diabetes, ARIC

A Multicenter, Multinational, Observational Study to Characterize Growth in Children with Idiopathic Short Stature

This research is being done to learn more about how children with idiopathic short stature grow. About 600 children with idiopathic short stature will be in this study across the world. The study will last a minimum of 6 months (i.e., three study visits). After a child has been in this study for at least 6 months, participants may be offered the option to exit this study and enroll in a different study with growth promoting agents.

Nishitha Pillai
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00021903
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Inclusion Criteria:

• participants must be at least 2 years old
• no more than 14 years old if female, or less than16 years old if male
• height Z-score is at least -2.5 SDs compared to age and sex matched norms
• able to walk ambulatory stand without assistance (not applicable for children who are less than 5 years of age and less than 104 cm i.e. 41 inches in length)
Exclusion Criteria:

• systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic or metabolic disease
• presence of one or more pituitary hormone deficiencies (ACTH [adrenocorticotropic hormone], ADH [antidiuretic hormone], FSH [follicle-stimulating hormone], GH [growth hormone], LH [luteinising hormone], TSH [thyroid-stimulating hormone]).
• diagnosis of hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated).
• Growth Hormone (GH) level below 10 ng/mL following a stimulation test. This does not apply to potential participants who are currently being treated with hGH for ISS
• known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turners syndrome, disproportionate skeletal dysplasias, abnormal short stature homeobox (SHOX) gene analysis, Rasopathy (including Noonan’s Syndrome), or absence of GH receptors
• bone age advanced over chronological age by more than 3 years
• active cancer, chemotherapy or radiation therapy
Children's Health, Diabetes & Endocrine, Rare Diseases, Rare Diseases
Growth, Growth Hormone, Idiopathic Short Stature, ISS
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FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults with Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis (Aim 3)

People with diabetes and their “Follower” (family member, friend, or caregiver) will participate together in 4+ sessions with a Certified Diabetes Care and Education Specialist over 90 days. Sessions can be completely virtual (via Zoom) or in person. Participants will receive a personalized Diabetes Action Plan to help navigate the challenges of living with diabetes. The “Follower” (family member, friend, or caregiver) will “follow” blood sugar data in real-time and assist their care partner with diabetes to “troubleshoot” using the Diabetes Action Plan.

Jacob Kohlenberg
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020104
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Inclusion Criteria:

• ages 18 to 65
• people with Type 1 Diabetes (T1DM) for at least 1 year
• HbA1C between 7.5% and 14.0%
• "Follower" (family member, friend, or caregiver who is at least 18 years old), willing to participate in the study and follow glucose data and has no self-reported cognitive impairment
Exclusion Criteria:

• active treatment with a sodium-glucose cotransporter-2 inhibitor or planning to start a sodium-glucose cotransporter-2 inhibitor in the next 6 months
• active cancer with the exception of non-melanoma skin cancer
• receiving hospice care
Diabetes & Endocrine
T1DM, Type 1 Diabetes
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Time Restricted Eating as a Viable Alternative to Caloric Restriction for Treating Hyperglycemia in a Population with Type 2 (T2DM) diabetes (SFS3)

Feasibility study to test our overall hypothesis that time restricted eating (TRE) presents a viable alternative to caloric restriction for improving glycemic measures and reducing weight in overweight/obese patients with metformin-only treated Type 2 diabetes (T2DM).

Lisa Chow
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014853
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Inclusion Criteria:

• adults who are overweight/obese and have type 2 diabetes treated only with metformin
• 18-65 years old
• BMI between 25-40 kg/m2
• HbA1c between 6.5-8.5%
• self reported weight must be stable (+/- 5 pounds) for at least 3 months prior to the study
• own a smartphone
Exclusion Criteria:

• women who are pregnant or are planning to become pregnant
• eating disorders
Diabetes & Endocrine
time restricted eatin, Type 2 diabetes, diet intervention, intermittent fasting, caloric restriction
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See this study on ClinicalTrials.gov

Liver Collection Study

This is a study of individuals older than 18, undergoing abdominal procedures in which the liver is accessible, and are amenable to liver samples being collected during their surgical procedure, with the option to participate in a specialized scan that can provide information on liver health, stiffness, and fat content. This study is trying to figure out how senescent (aging) cells in the liver are related to an individual's health status and better understand the association between these cells and different metabolic diseases.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013764
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Inclusion Criteria:

• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
Exclusion Criteria:

• Pregnancy or nursing
• Physician may exclude
Diabetes & Endocrine, Digestive & Liver Health, Prevention & Wellness
abdominal surgery, liver biopsy
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Profiling of Adipose Tissue Depots and Immune Correlates

This is a study of individuals older than 18, undergoing abdominal surgery, and are amenable to fat samples being collected during their surgical procedure, with the option to participate in other tests that can provide information on insulin sensitivity and fat distribution. This study is trying to figure out how fat tissue is related to an individual's health status and health conditions, and the analysis of the aging of cells that make up the human body.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00009134
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Inclusion Criteria:

• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
Exclusion Criteria:

• Pregnancy or nursing
• Exclusion at the discretion of attending physician or Eligibility Committee
Digestive & Liver Health, Diabetes & Endocrine, Prevention & Wellness
abdominal surgery, fat collection
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Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years

This study will enroll children aged 6 to 12 years who have difficulty in maintaining a healthy weight and see if the medication Vyvanse may help them to reduce their weight.

Claudia Fox
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00019097
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Inclusion Criteria:

• children 6 to 12 years old
• severe obesity defined as BMI greater than or equal to 1.2 times the 95th percentile
• failed attempt of lifestyle therapy
Exclusion Criteria:

• significant congenital or structural heart disease or arrhythmia
• hypertension
• history of chemical dependency
• Diabetes mellitus (type 1 or 2)
• current or recent ( less than 3 months ago) use of anti-obesity medication(s)
• additional medical or mental health conditions (study staff will review)
Children's Health, Diabetes & Endocrine
healthy weight, Obesity
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See this study on ClinicalTrials.gov

Lifestyle Counseling and Medication for Adolescent Weight Management (QUEST)

This study will compare the effectiveness and durability of intensive behavioral counseling vs. medical management plus low-intensity behavioral counseling on BMI, body fat, cardiometabolic risk factors, and quality of life in adolescents with severe obesity. We hypothesize that Wegovy (semaglutide) plus low-intensity behavioral counseling will elicit superior reductions in BMI and body fat and greater improvement in cardiometabolic factors and quality of life compared to intensive behavioral counseling at 56 weeks.

Aaron Kelly
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00012932
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Inclusion Criteria:

• ages 12-17
• BMI greater than or equal to the 95th percentile for age and sex
Exclusion Criteria:

• Type 1 or Type 2 diabetes
• use of medications for obesity in the past 6 months
• any treatment with growth hormone
• bariatric surgery -major mental health diagnosis (study staff will review)
• pregnant or plan to become pregnant
• significant medical diagnosis (study staff will review)
Diabetes & Endocrine, Children's Health
Obesity, Overweight, weight loss
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Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents with Severe Obesity

In this study we want to find out more about weight loss and how diet and medications can affect weight loss. This study will last for up to 58 weeks. There are two phases to the study: - A weight loss phase with prescribed meals that lasts 6 weeks. - A study medication/placebo phase that lasts up 52 weeks. You will not know if you are receiving the medication or the placebo.

Aaron Kelly
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00008743
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Inclusion Criteria:

• severe obesity (BMI >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)
• 12 to less than 18 years of age at enrollment
• female participants who are sexually active with males and who are able to get pregnant must agree to use two forms of contraception throughout the trial
Exclusion Criteria:

• diabetes (type 1 or 2)
• current or recent (< six months prior to enrollment) use of anti-obesity medication(s) (use of naltrexone or bupropion alone is not an exclusion)
• previous metabolic/bariatric surgery
• current use of a stimulant medication
• history of glaucoma
• current or recent (<14 days) use of monoamine oxidase inhibitor
• history of treatment with growth hormone
• history of bulimia nervosa
• major psychiatric disorder
• any history of active suicide attempt
• history of suicidal ideation or self-harm within the previous 30 days
• current pregnancy or plans to become pregnant during study participation
• current tobacco use
• history of cardiac, endocrine, kidney disease (study staff will review)
Children's Health, Diabetes & Endocrine
Clinics and Surgery Center (CSC), Obesity, overweight, weight loss
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Rituximab-PVVR followed by Abatacept Versus Rituximab-PVVR Alone In New Onset Type 1 Diabetes (TN25)

This study is to see if giving the medications rituximab-pvvr (Ruxience®) followed by abatacept can help preserve remaining insulin secretion if given within three months of being diagnosed with type 1 diabetes (T1D).

Antoinette Moran
Not specified
This study is NOT accepting healthy volunteers
STUDY00021237
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Inclusion Criteria:

• 8 to 45 years old
• diagnosis of Type 1 Diabetes within 100 days of starting the study
• positive for at least one islet cell autoantibody
• willing to comply with intensive diabetes management
• willing to wear a continuous glucose monitoring device for a minimum of 10 days every 6 months
• weigh at least 20kg (44 pounds)
• up to date on all recommended vaccinations based on age
• willing to practice public health prevention measures such as social distancing, masking, and good hand hygiene, and/or receive therapeutics such as monoclonal antibodies and antivirals as directed by the study and recommended by local health authorities to prevent SARS-Cov-2 infection
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• history of immune deficiency
• chronic active infection other than localized skin infections
• current or past HIV or Hepatitis B or active Hepatitis C infection
• women who are pregnant, breast feeding, or anticipate pregnancy
• use of oral or inhaled steroids or other immunosuppressive agents
• history of cancer
Diabetes & Endocrine
DM, T1D, Type 1 Diabetes
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Understanding modifiable barriers to treatment adherence in youth with type 2 diabetes to inform intervention development

This study will seek to learn about barriers to management of Type 2 diabetes for children ages 10-17. This study is recruiting children, and their parent/guardian, who are managing with oral medication or insulin.

Amy Noser
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00019484
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Inclusion Criteria:

• 10 to 17 years old
• confirmed diagnosis of type 2 diabetes
• prescribed pharmacologic therapy for treatment of type 2 diabetes (oral medication or insulin)
• live with a parent/caregiver at least 50% of the time who is willing to participate in the study
• able to read and speak English
• the parent/caregiver must be the adult who spends the largest proportion of time caring for the child (or at least 50%) & able to speak and read English
Exclusion Criteria:

• diagnosis of type 1 or monogenic diabetes
• evidence of significant cognitive deficits or a severe, persistent psychiatric disorder
Children's Health, Diabetes & Endocrine
Type 2 Diabetes
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JAK Inhibitors to Preserve C-Peptide Production in New Onset T1D: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subtype-Selective JAK Inhibitors for Preservation of Pancreatic Cell Function in Newly Diagnosed Type 1 Diabetes Mellitus

This is a new type 1 diabetes onset study for ages 12-35 years old. We are looking at JAK inhibitor drugs to see if they can preserve beta cell function.

Antoinette Moran
Not specified
This study is NOT accepting healthy volunteers
SITE00001949
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Inclusion Criteria:

• age 12-35 years (inclusive)
• diagnosis of T1D within 100 days of first study visit
• positive for at least one islet cell autoantibody
• HbA1c no more than 10 %
• body weight at least 35kg (77 pounds)
• willing to comply with intensive diabetes management and wear a Continuous Glucose Monitoring Device (CGM)
• up to date on recommended immunizations (including flu and COVID-19)
• willing to use highly effective contraception for 3 months after the last dose of study medication
Exclusion Criteria:

• current use of a medication that affects glucose control
• treatment with other immunosuppressive agents (including biologics or steroids), other than inhaled or topical glucocorticoids
• current history of infection (HIV, Hepatitis B, TB, herpes etc.)
• current or past use of tobacco or nicotine containing products more than the equivalent of 5 cigarettes per day
• current or past medical or mental health conditions (study staff will review)
• women who are pregnant, breast feeding, or planning to become pregnant
Children's Health, Diabetes & Endocrine
T1D, new onset, type 1 diabetes,
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Feasibility of a text message intervention in Hmong community

We are conducting this research to better understand if text messages can be used for diabetes education for patients in the Hmong community. People will be in this research study for one month. You will receive two text messages per week for one month and be asked to complete a 5-10 minute survey at the end of the month.

Katherine Montag-Schafer
18 years and over
STUDY00021632
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Inclusion Criteria:

• identify self as Hmong
• have diabetes
• receive care at the Phalen Village Clinic
• have a cell phone that can receive text messages
Exclusion Criteria:

• under 18 years old
Diabetes & Endocrine
Diabetes, Hmong
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Influence of Exercise on the Gut Microbiome of Overweight and Obese Adults with Prediabetes

We are looking at how an 8-week exercise program of walking for 30-45 minutes 3 times/week affects the body. This study is for people who are prediabetic and overweight or obese. We will compare the exercise group to a group that didn’t participate in the exercise to see if there are differences in gut microbes, body measurements, and blood work.

Ryan Demmer
18 years and over
This study is NOT accepting healthy volunteers
STUDY00009136
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Inclusion Criteria:

• 30-64 years old
• classified as overweight or obese with BMI greater than 25 kg/m2
• physician diagnosed as pre-diabetic or HbA1c value of 5.7 - 6.4% obtained during study screening
• currently exercise less than 100 minutes per week
• physically able to exercise
• no antibiotics taken for at least 45 days
• weight has been stable for the last 6 months (less than 10% change)
• willing to maintain current diet and exercise levels unless changed by the study
Exclusion Criteria:

• current gastrointestinal illness
• taking metformin or other medications for high blood sugar
• history of bariatric surgery
• pregnant or breast feeding
Diabetes & Endocrine
Prediabetes, elevated blood glucose, impaired glucose, blood sugar, obesity, Hemoglobin A1c, exercis
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Sex differences in the effecTs of brEaking uP sedentary behavior on vascUlar function in Type 2 Diabetes (STEP UP T2D)

Type 2 diabetes (T2D) confers a high risk of cardiovascular disease (CVD), particularly among older adults who tend to be physically inactive. Most studies that have examined the effects of changing sedentary behavior (SB) have focused on young healthy males and prioritized glycemic outcomes. We will look at the effect of 3 different ways of breaking up sitting: 1) 4 hours of prolonged SB, 2) 4 hours of SB broken up by 5 minutes of self-paced walking every hour, and 3) 4 hours of SB with one 20-minute bout of self-paced walking. In addition to examining the overall effects of each condition, differences between men and women will be evaluated.

Mary Whipple
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018030
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Inclusion Criteria:

• men who are 60 years or older
• Type 2 diabetes (hemoglobin A1c 6.5% or more and/or previous diagnosis of type 2 diabetes)
• sedentary for at least 6 hours/day
• willing to abstain from food, caffeine, alcohol and exercise for at least 24 hours, and tobacco/smoking for at least 12 hours prior to each study visit
• able to speak and read English
Exclusion Criteria:

• Type 1 diabetes
• uncontrolled hypertension (resting systolic greater than 160 or diastolic greater than 110 mmHg)
• starting hormone therapy or changing in hormone therapy (dose/frequency/route of administration) in the previous 3 months
• on renal dialysis
• history of deep vein thrombosis (DVT)
• evidence of cognitive impairment
• physical impairment or disability that interferes with ability to engage in exercise (severe osteoarthritis, lower extremity amputation [other than toe(s)/partial foot], use of a walker or wheelchair, etc.)
• unstable medical/psychiatric condition that could impact study participation
Diabetes & Endocrine, Prevention & Wellness, Women's Health
physical activity, sedentary behavior, sitting
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Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus

The purpose of this research study is to learn more about how food affects blood sugar levels, and whether a continuous glucose monitor (CGM) can help to individualize nutrition education for people with diabetes. Participation in the study would require 3-4 clinic visits over a period of 14 weeks. Participants will also be asked to: meet with a registered dietitian every 2 weeks (virtually), keep food logs, wear a CGM and an activity monitor, answer survey questions, and provide blood samples to measure markers of diabetes control (like hemoglobin A1c).

Anne Bantle
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019848
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Inclusion Criteria:

• at least 18 years of age
• diagnosis of type 2 diabetes mellitus
• Hemoglobin A1c of 7.0 - 9.5%
• Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period
Exclusion Criteria:

• Type 1 diabetes mellitus
• treatment with insulin, sulfonylurea, or meglitinide
• use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)
• BMI < 25 kg/m2
• weight change > 5 pounds in the 3 months prior to study enrollment
• estimated glomerular filtration rate <60 ml/minute/1.73 m2
• pregnant or breastfeeding
• anemia
• presence of any disease that would make adherence to the protocol difficult
Diabetes & Endocrine
Diabetes, T2D, Type 2 Diabetes
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A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated with Lonapegsomatropin (SkyPASS) (SkyPASS)

The purpose of this study is to evaluate the long-term safety and effectiveness of Skytrofa treatment in children growth hormone deficiency. Patient care will follow the normal treatment practices at the clinic. No additional visits will be performed beyond the usual clinical practice.

Brad Miller, MD, PhD
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00002030
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Inclusion Criteria:

• 1 to 18 years old
• on treatment with SKYTROFA (lonapegsomatropin)
Exclusion Criteria:

• participating in any interventional clinical study for short stature
Diabetes & Endocrine, Rare Diseases, Rare Diseases, Rare Diseases
growth hormone and growth hormone deficiency

Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly versus Placebo in Adolescent Participants Who have Obesity, or are Overweight with Weight-Related Comorbidities: A Randomized, Double-Blind Trial

This study is being done to see how safe an investigational drug is and how well it will work to help people with obesity, or overweight with weight-related conditions like hypertension, dyslipidemia, obstructive sleep apnea, non-alcoholic fatty liver disease, or diabetes. If you qualify to be in the study, you will be given frequent lifestyle and behavioral counseling for the first 12 weeks of the study. The counseling will consist of advice on physical activities and dietary advice on healthy eating. During the treatment period, you will receive either tirzepatide or placebo. Placebo is a solution that looks like the study drug but has no medicine. The chance that you will get the study drug is 2 in 3. This phase will last about 72 weeks.

Claudia Fox
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00019351
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Inclusion Criteria:

• 12 to 17 years old
• have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart
• OR be overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity. These include: dyslipidemia, pre-hypertension, hypertension, nonalcoholic fatty liver disease, obstructive sleep apnea, prediabetes, or Type 2 Diabetes
• those with Type 2 Diabetes have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c<9.0% Type 2 Diabetes
Exclusion Criteria:

• decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days
• have Type 1 Diabetes
• have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction
• have or plan have a weight reduction surgical procedure
• additional exclusion criteria apply (study staff will review)
Children's Health, Diabetes & Endocrine
BMI, Obesity, Overweight, T2D, Type 2 Diabetes
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See this study on ClinicalTrials.gov

INHALE-1: A 26-week Primary Treatment Phase, with 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza® Versus Rapid-acting Insulin Analog Injections, Both in Combination with a Basal Insulin, in Pediatric Subjects with Type 1 or Type 2 Diabetes Mellitus (INHALE-1)

To assess the safety of Afrezza in a pediatric population when compared to the usual standard of care insulin.

Muna Sunni
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001625
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Inclusion Criteria:

• 4 years to under 18 years old
• diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM)
• using insulin for at least 6 months for T1DM, or at least 3 months for T2DM
• treated with basal-bolus insulin therapy delivered by multiple daily injections for at least 2 weeks
• bolus insulins are restricted to the RAAs insulin lispro, insulin aspart or insulin glulisine, including biosimilar products
• basal insulins are restricted to insulin glargine, insulin degludec or insulin detemir, including biosimilar products
• HbA1c between 7.0% and 11%
• average prandial dose of insulin 2 or more units per meal
• used CGM for at least 70% of the time over a consecutive 14-day period before starting the study
• access to stable WiFi connection
Exclusion Criteria:

• history of recent blood transfusions (within previous 3 months)
• recent history of asthma (defined as using any medications to treat within the last year) or any other clinically important lung disease
• history of serious complications of diabetes
• any other illness that isn't stable (study staff will review)
• uncontrolled eating disorder (e.g., anorexia or bulimia nervosa)
• current drug or alcohol abuse or a history of drug or alcohol abuse
• smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) for the preceding 6 months
Diabetes & Endocrine
diabetes, insulin, type 1 diabetes, type 2 diabetes
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See this study on ClinicalTrials.gov

Collaborative Solutions for Breaking Up Sedentary Time in Black Older Adults with Type 2 Diabetes: The Interrupt T2D Study

Black Americans are 60% more likely to be diagnosed with Type 2 Diabetes (T2D) and 2 times more likely to die from T2D than non-Hispanic White Americans. Recent research has shown that sedentary behavior (such as sitting or lying down) have a significant negative impact on health. We are doing a small study with older people who identify as Black or African American and have T2D to look at ways to reduce sedentary behavior. The study will last about 1-2 months for each participant.

Mary Whipple
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021174
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Inclusion Criteria:

• self-identify as Black or African American.
• 55 years and older
• speak and read English.
• self-reported diagnosis of type 2 diabetes (T2D)
Exclusion Criteria:

• evidence of cognitive impairment that could impact ability to consent and/or participation
• physical impairment or disability that interferes with ability to engage in physical activity such as severe osteoarthritis, lower extremity amputation (other than toe(s) or partial foot), regular use of a walker or wheelchair, etc.
• unstable medical or mental health condition (study staff will review)
Diabetes & Endocrine, Heart & Vascular, Prevention & Wellness
behavior change, community engaged research, diabetes, physical activity, sedentary behavior, T2D
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The TrialNet Natural History Study of the Development of Type 1 Diabetes

TrialNet is an international research group dedicated to the study, prevention, and early treatment of Type 1 diabetes. Type 1 diabetes is now understood as a disease that develops over time in stages. Stage 1 starts with the appearance of having two or more autoantibodies. This is followed by Stage 2, which is the development of abnormal blood glucose levels. Stage 3 is the clinical diagnosis of Type 1 diabetes. This study will help us learn more about how Type 1 diabetes occurs through the screening of diabetes-related autoantibodies and monitoring individuals who have tested positive for these autoantibodies.

Antoinette Moran
Not specified
This study is also accepting healthy volunteers
SITE00000016
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Inclusion Criteria:

• 2.5 to 45 years old and have an immediate family member with type 1 diabetes (child, parent, or sibling)
• 2.5 to 20 years old who have an extended family member with type 1 diabetes (cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
Exclusion Criteria:

• already have diabetes
• history of being treated with insulin or oral diabetes medications
• using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
• have any known serious diseases
Diabetes & Endocrine
T1DM, Type 1 Diabetes

Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM) (DREAM)

The purpose of this research study is to find out how many people with acute pancreatitis develop diabetes. Risk factors for diabetes and the types of diabetes that occur after acute pancreatitis will also be studied. A small number of people who already had diabetes before their acute pancreatitis attack will be enrolled for comparison.

Melena Bellin
18 years and over
This study is NOT accepting healthy volunteers
SITE00001256
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Inclusion Criteria:

• diagnosis of acute pancreatitis no more than 90 days ago
Exclusion Criteria:

• definite diagnosis of chronic pancreatitis based on results of scans (study staff will review)
• pancreas tumors
• prior surgery on the pancreas
• pregnancy
• other significant health problems, study staff will review
Diabetes & Endocrine, Digestive & Liver Health
Diabetes, Pancreatitis, Pancreas
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Measurement of Glucose Homeostasis in Human Brain by NMR: Effect of Recurrent Hypoglycemia on Type 1 Diabetes (Aim 2)

Individuals with type 1 diabetes often develop an impaired awareness of hypoglycemia (IAH), meaning they are not fully aware of having low blood glucose levels. This research study is looking to determine what happens in the brain after repeat episodes of hypoglycemia.

Elizabeth Seaquist
18 years and over
STUDY00008108
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Inclusion Criteria:

• 18 to 65 years old
• diagnosis of Type 1 diabetes
• diabetes duration 2 - 30 years
• Hemoglobin A1C less than 8.5%
Exclusion Criteria:

• unaware of hypoglycemia when it is occurring
• pregnant or plan to become pregnant during the study
• uncontrolled hypertension (blood pressure greater than 145/95 mmHg)
• inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 pounds
• other medical or mental health issues (study staff will review)
Diabetes & Endocrine
Diabetes Mellitus, Type 1
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See this study on ClinicalTrials.gov