Intervention: Metformin
Trial phase: Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 76
Group description: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.

Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
Eligibility criteria:
Inclusion Criteria:

Premenopausal women
21-54 years of age
Have a BMI of 25 kg/m2 or greater
No change in menstrual patterns for the past 6 months preceding the time of registration
Waist circumference ≥ 35 inches or ≥ 31 inches for Asian Americans, individuals with polycystic ovary syndrome, or individuals with non-alcoholic fatty liver disease.

Have at least one other component of metabolic syndrome (103) reported below:

Elevated triglycerides (≥ 150 mg/dL (1.7 mmol/L) or on drug treatment for elevated triglycerides
Reduced HDL-C (< 50 mg/dL (1.3 mmol/L) or on drug treatment for reduced HDL-C
Elevated blood pressure (≥ 130 Hg systolic blood pressure or ≥85 mm Hg diastolic blood pressure or on antihypertensive drug treatment in a patient with a history of hypertension
Elevated fasting glucose (≥100 mg/dL)
Mammogram negative for breast cancer within the 12 months preceding the time of registration for women ≥ 50 years of age
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Postmenopausal women

Amenorrhea for at least 12 months (preceding the time of registration), or
History of hysterectomy and bilateral salpingo-oophorectomy, or
At least 55 years of age with prior hysterectomy with or without oophorectomy, or
Age 35 to 54 with a prior hysterectomy without oophorectomy OR with a status of ovaries unknown with documented follicle-stimulating hormone level demonstrating elevation in postmenopausal range
Women who are pregnant, planning pregnancy within the next year, or breastfeeding
On treatment with any drug for diabetes
Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any illness that would limit compliance with study requirements
Have received chemotherapy and/or radiation for any malignancy (excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment) in the past 5 years (preceding the time of registration)
Have received other investigational agents within the past 3 months (preceding the time of registration)
Have a history of lactic acidosis or risk factors for lactic acidosis
Have significant renal disease or dysfunction (creatinine ≥ 1.4 mg/dL)
Have significant hepatic dysfunction (bilirubin ≥ 1.5 x ULN unless with Gilberts syndrome or AST/ALT ≥ 3 x ULN)
Have a history of alcoholism or high alcohol consumption (average of > 3 standard drinks/day)
Have a history of allergic reactions to metformin or similar drugs
Have a history of severe claustrophobia
Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses
Have breast implants