Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT01697566
Eligibility Criteria:
Inclusion Criteria:
1. For this study, only women will be enrolled.
2. Body Mass Index (BMI) \> or = 30 kg/m2
3. Not frankly diabetic, as measured by a fasting blood glucose \</=126 mg/dL.
4. Demonstrate hyperinsulinemia with a QUICK I value \</= 0.357.
5. Age \>/= 50 and \</= 65
6. Zubrod Performance Scale 0-1
7. Hemoglobin \>/= 10 g/dl
8. TSH 0.27 - 4.20 µlU/mL
9. Menopause as defined as no menses for 1 year and/or FSH \>/= 25.8 mIU/ml
10. Must be able to read, write, and speak English.
11. Must have a Primary Care Provider (PCP).
Exclusion Criteria:
1. Prior hysterectomy or endometrial ablation
2. ALT \>/r = 2.0x Upper Limit of Normal (ULN)
3. Serum creatinine \> /= 1.4 mg/dl
4. Triglycerides (fasting) \>/ = 400
5. Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.
6. 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.
7. Participant reported history of congestive heart failure
8. Prior treatment with Metformin
9. Currently being treated for diabetes or meeting criteria for new diagnosis of diabetes.
10. Known allergy to Metformin or other biguanide (Proguanil).
11. Use of Aromatase Inhibitors, GNRH-agonists i.e.Lupron, Zoladex within the last 6 months
12. Use of SERMS (selective estrogen receptor modulators) in the past 6 months, including Tamoxifen and Raloxifene
13. Hormone replacement therapy within the last 6 months
14. Women who have been treated with chemotherapy for prior malignant disease or currently have an untreated malignancy other than non-melanoma skin cancer
15. Patients who have had prior radiation to the pelvis
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
65 Years
Study:
NCT01697566
Study Brief:
Protocol Section:
NCT01697566