An Endometrial Cancer Chemoprevention Study of Metformin (NCT01697566) | Clinical Trial Compass
CompletedPhase 3
An Endometrial Cancer Chemoprevention Study of Metformin
United States29 participantsStarted 2013-05-30
Plain-language summary
The goal of this clinical research study is to learn about the effects of metformin and/or a program called "lifestyle intervention" on the endometrium (inner lining of the uterus) in post-menopausal women who are also obese (both are risk factors for endometrial cancer). Researchers also want to learn how insulin levels will be affected by metformin, diet and/or exercise.
Metformin is designed to treat both diabetes and insulin resistance. Insulin resistance is a condition in which the body makes insulin but does not use it properly. It is often referred to as "pre-diabetes". Many people with insulin resistance have high levels of both sugar and insulin in their blood at the same time, which have been reported in patients with endometrial cancer.
In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Lifestyle intervention is made up of a series of in-person sessions where you meet with a coach to discuss strategies for losing weight and ways to increase physical activity. It also consists of materials designed to help you lose weight and will offer opportunities for supervised exercise.
Who can participate
Age range50 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. For this study, only women will be enrolled.
✓. Body Mass Index (BMI) \> or = 30 kg/m2
✓. Not frankly diabetic, as measured by a fasting blood glucose \</=126 mg/dL.
✓. Demonstrate hyperinsulinemia with a QUICK I value \</= 0.357.
✓. Age \>/= 50 and \</= 65
✓. Zubrod Performance Scale 0-1
✓. Hemoglobin \>/= 10 g/dl
✓. TSH 0.27 - 4.20 µlU/mL
Exclusion criteria
✕. Prior hysterectomy or endometrial ablation
✕. ALT \>/r = 2.0x Upper Limit of Normal (ULN)
✕. Serum creatinine \> /= 1.4 mg/dl
✕
What they're measuring
1
To Evaluate the Participant Body Weight in Pounds (Lbs)
Timeframe: Visit 2 (1 week), 4 months, and 1 year
2
To Evaluate the Percentage of Ki-67 Positive Cells
✕. Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.
✕. Significant medical or psychiatric history which would make the participant a poor protocol candidate, in the opinion of the principal investigator, for any aspect of study participation including metformin, unsupervised exercise program or dietary behavior change.
✕. Participant reported history of congestive heart failure