Insulin Resistance and Testosterone in Women
Condition: Insulin Resistance; Postmenopause
MeSH terms: Insulin Resistance
Intervention: metformin; leuprolide injection; placebo pill; placebo injection
Intervention description: Initiated on 500 mg daily and titrated up to 1000 mg twice a day during the first four weeks, remaining at that dose until 12 weeks; 3.75 mg injection every 4 weeks (e.g. at baseline, 4, and 8 weeks); matching pill twice a day for 12 weeks; matching injection every 4 weeks (e.g. baseline, 4, and 8 weeks)
Intervention MeSH terms: Metformin; Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: Female
Minimum age: 50 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this research study is to determine if a relationship between insulin
      resistance (IR) and testosterone (T) exists in women who have already gone through menopause.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women aged 50-79 years with absence of menses for 12 months; for women
             50-54 years, Follicle stimulating hormone>30 U/mL to confirm postmenopausal status

          -  At least one intact ovary

          -  Free testosterone and fasting insulin levels within required study parameters

          -  Willing to comply with all study-related procedures

          -  Capable of giving informed consent

        Exclusion Criteria:

          -  History of cancer requiring treatment within the past 5 years (exceptions may be made
             by investigator)

          -  Hospitalization for treatment of vascular disease in the past 6 months

          -  Uncontrolled hypertension

          -  Hospitalization for chronic obstructive pulmonary disease or asthma in the past 3
             months

          -  Use of continuous oxygen at home

          -  Surgery in the last 30 days

          -  Positive for HIV

          -  Abnormal blood tests (hemoglobin, fasting triglycerides, fasting glucose, creatinine,
             liver function)

          -  History of diabetes mellitus or use of any anti-hyperglycemic medication in the past 3
             months

          -  Disease associated with disordered glucose metabolism (Cushing's disease, acromegaly,
             pheochromocytoma not surgically cured, chronic pancreatitis)

          -  History of chronic renal insufficiency

          -  Intravenous (IV) contrast studies with iodinated materials planned for the 12 week
             intervention period that cannot be postponed according to the participant's primary
             care provider

          -  Acute or chronic metabolic acidosis

          -  History of liver disease

          -  Congestive heart failure

          -  History of androgen-secreting tumors

          -  Hormone replacement therapy or antiandrogen use in past 6 months

          -  Use of dehydroepiandosterone (DHEA) or other androgen-containing products in past 6
             months

          -  Corticosteroid use, other than topical, ophthalmic, intraarticular, and inhaled
             preparations, in past 3 months

          -  Undiagnosed current vaginal bleeding

          -  Excessive alcohol intake, either acute or chronic; current illicit substance abuse

          -  Participation in an investigational drug study within 6 weeks prior to screening visit

          -  Serious or unstable medical or psychological conditions that, in the opinion of the
             investigator, would compromise the patient's safety or successful participation in the
             study