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Search Results Within Category "Diabetes & Endocrine"

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18 Study Matches

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.

Principal Investigator: Aaron Kelly
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: 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)
Conditions: Diabetes & Endocrine, Children's Health
Keywords: Obesity, Overweight, weight loss
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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.

Principal Investigator: Antoinette Moran
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Children's Health, Diabetes & Endocrine
Keywords: T1D, new onset, 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.

Principal Investigator: Amy Noser
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Children's Health, Diabetes & Endocrine
Keywords: Type 2 Diabetes
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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.

Principal Investigator: Claudia Fox
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: 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)
Conditions: Children's Health, Diabetes & Endocrine
Keywords: healthy weight, Obesity
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A Multicenter 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.

Principal Investigator: Nishitha Pillai
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Children's Health, Diabetes & Endocrine, Rare Diseases, Rare Diseases
Keywords: Growth, Growth Hormone, Idiopathic Short Stature, ISS
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CPDPC16-04: Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabeTes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT)

Diabetes mellitus is a common condition which is defined by persistently high blood sugar levels. This is a frequent problem that is most commonly due to type 2 diabetes. However, it is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis or pancreatic cancer, as the cause of their diabetes. Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas. The goal of this study is to develop a blood test to distinguish these various causes of diabetes.

Principal Investigator: Melena Bellin
Age Group: 18 years and over
IRB Number: SITE00001191
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Inclusion Criteria:

• 30 to 84 years old
• diabetes diagnosed less than 3 years ago with Pancreatic Cancer or Chronic Pancreatitis or no disease of the pancreas
• OR longstanding diabetes diagnosed 3 or more years ago, with Pancreatic Cancer or Chronic Pancreatitis or no disease of the pancreas
• OR people don't have diabetes but have Pancreatic Cancer or Chronic Pancreatitis or no disease of the pancreas
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• currently receiving oral steroid medications
• previous treatment for pancreatic cancer, including chemotherapy or radiation
• on treatment for any cancer
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Diabetes & Endocrine
Keywords: Chronic Pancreatitis, Diabetes Mellitus Type 3c, Pancreatic Cancer
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Non-Invasive Sleep and Circadian Rhythm Assessment Pre- and Post-surgery in Cushing Disease

The goal of this study is to see if using in-home sleep activity monitoring may help understand sleep problems that occur before and after surgical treatment for Cushing Disease.

Principal Investigator: Takako Araki
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022764
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Inclusion Criteria:

• Aged 18 years or older
• Their own legal guardian
• Confirmed Cushing's Disease (CD) by biochemical test and brain MRI imaging
• Scheduled for surgery to treat CD
• Receiving care through an Endocrinology or Neurosurgery clinic
• Able to complete the self-report their health/wellbeing and sleep diary information
Exclusion Criteria:

• Biochemical and/or brain MRI imaging test with inconclusive results
• Patients not electing for surgical intervention for CD
Conditions: Breathing, Lung & Sleep Health, Diabetes & Endocrine, Rare Diseases
Keywords: CD, Cushing Disease
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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.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: 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)
Conditions: Children's Health, Diabetes & Endocrine
Keywords: Central Precocious Puberty, CPP, Early Puberty, Precocious Puberty, Puberty

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.

Principal Investigator: Pamela Lutsey
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Diabetes & Endocrine, Heart & Vascular
Keywords: aging, cognition, heart disease, Type 2 Diabetes, ARIC

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.

Principal Investigator: Jacob Kohlenberg
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Diabetes & Endocrine
Keywords: 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)

The purpose of the study is to see how restricting the eating window (called time-restricted eating) might affect eating habits, weight, and blood measures compared to reducing food intake. Time-restricted eating means that people would have a daily 8 hour eating window during which time they can eat whatever they want. Outside of the eating window, people would only take water and your medications. We expect that participants will be in this research study for about 7 months.

Principal Investigator: Lisa Chow
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014853
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Inclusion Criteria:

• 18 to 65 years old
• overweight/obese and have type 2 diabetes treated with diet or metformin
• BMI between 25-45 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
Conditions: Diabetes & Endocrine
Keywords: Type 2 diabetes, intermittent fasting, caloric restriction, time restricted eating
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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.

Principal Investigator: Ryan Demmer
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Diabetes & Endocrine
Keywords: 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.

Principal Investigator: Mary Whipple
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Diabetes & Endocrine, Prevention & Wellness, Women's Health
Keywords: 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).

Principal Investigator: Anne Bantle
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Diabetes & Endocrine
Keywords: 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.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Diabetes & Endocrine, Rare Diseases, Rare Diseases, Rare Diseases
Keywords: growth hormone and growth hormone deficiency

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.

Principal Investigator: Mary Whipple
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 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)
Conditions: Diabetes & Endocrine, Heart & Vascular, Prevention & Wellness
Keywords: 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.

Principal Investigator: Antoinette Moran
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: 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
Conditions: Diabetes & Endocrine
Keywords: 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.

Principal Investigator: Melena Bellin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Diabetes & Endocrine, Digestive & Liver Health
Keywords: Diabetes, Pancreatitis, Pancreas
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