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UAZ21-07-01 Metformin Study

Status: Recruiting

In this study we will test whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose patients absorb from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood. This trial may help researchers determine if metformin can stop changes in the mouth that are related to pre-cancer growths in the mouth.

I'm interested

Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 21 years old
• diagnosis of oral leukoplakia or erythroplakia (white or red patches in the mouth)
• current and former smokers (>= 5 packs in the lifetime)
• willing to use adequate contraception for the duration of study participation
• able to take oral medication
• understand English or Spanish
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• people with diabetes who are being treated with insulin or an anti-diabetic medication
• history of diabetic ketoacidosis
• Hemoglobin A1c (HbA1c) > 8%
• history of chronic alcohol use
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions:

Cancer, Prevention & Wellness

Keywords:

Clinics and Surgery Center (CSC), Erythroplakia, Oral Leukoplakia

Study Contact: Beverly Wuertz - knier003@umn.edu
Principal Investigator: Frank Ondrey
Phase: PHASE2
IRB Number: SITE00001629
See this study on ClinicalTrials.gov

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