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Insulin Resistance and Testosterone in Women

This study is currently recruiting participants.
Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  Insulin Resistance and Testosterone in Women
Official Title  Insulin Resistance and Testosterone in Non-Diabetic Postmenopausal Women
Brief 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.

Detailed Description

This study tests the central hypothesis that insulin resistance (IR) increases androgen (male sex hormone) production in postmenopausal women. Participation will include five visits, each lasting on average 2.5 hours, over a period of 13-20 weeks.

At the screening visit, the participant's medical history, current use of medications and dietary supplements, and social habits will be recorded. This information will be reviewed on each subsequent visit; participants are asked to maintain their current diet and physical activity level throughout the study.

A brief physical exam will be performed, and blood will be drawn.

At the 2nd (baseline) visit, patients will undergo a euglycemic-hyperinsulinemic clamp (a procedure to measure insulin sensitivity by continuous intravenous infusion of insulin, and variable infusion of glucose). Blood samples will be drawn throughout the procedure. At completion, the insulin infusion will be stopped, participants will be fed, and the glucose infusion continued for at least 15 minutes to ensure stability of the blood glucose concentration. After the procedure, participants will be randomized to receive either metformin plus leuprolide placebo, leuprolide plus metformin placebo, or metformin placebo plus leuprolide placebo. The leuprolide or leuprolide placebo will be administered as an injection by a nurse. The metformin or metformin placebo will be dispensed to the participant in the form of pills, with instructions for titrating the dose. Participants will be contacted by telephone once weekly during the titration period to assess drug tolerability and adverse events (AEs). Participants will be maintained at their maximum tolerated dose for the duration of the study intervention period.

Participants will return every 4 weeks for follow-up. Blood will be drawn, the nurse will administer the leuprolide or leuprolide placebo injection, and metformin or metformin placebo will be dispensed. At the final visit (week 12), participants will undergo a brief physical exam, and will then undergo a final euglycemic-hyperinsulinemic clamp.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Free testosterone
Insulin resistance
Secondary Outcome Measure  Luteinizing hormone (LH), follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG), estradiol, total testosterone, dehydroepiandrosterone sulfate (DHEA-S)
Homeostasis model assessment index of insulin resistance (HOMA-IR)
Lipid profile including high-density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides (TG), total cholesterol, surrogate measures of adiposity including body mass index (BMI), waist-to-hip ratio (WHR), and waist circumference
Systolic (SBP) and diastolic (DBP) blood pressure
Free T and IR in women in whom Metabolic Syndrome (MetSyn, as defined by updated NCEP ATP III criteria) is present vs. those in whom MetSyn is absent
Condition  Insulin Resistance
Postmenopause
Intervention  Drug: metformin
Drug: leuprolide acetate
MEDLINE PMIDs 11790215,   15353414,   8941471,   11772901
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  45
Start Date  July 2005
Completion Date March 2008
Eligibility Criteria 

Inclusion Criteria:

  • Postmenopausal women aged 50-79 years with absence of menses for 12 months; for women 50-54 years, FSH>30 mIU/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 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
Gender Female
Ages 50 Years to 79 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Theresa Scattergood, RN, MSN     215-898-5664     theresa.scattergood@uphs.upenn.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00123110
Organization ID AG0031
Secondary IDs †† K23AG1916101A1, 5P30DK019525
Study Sponsor  National Institute on Aging (NIA)
Collaborators †† The John A. Hartford Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pennsylvania Diabetes and Endocrinology Research Center (DERC)
TAP Pharmaceutical Products Inc.
Investigators 
Principal Investigator:     Anne R. Cappola, MD, ScM     University of Pennsylvania    
Information Provided By National Institute on Aging (NIA)
Verification Date September 2007
First Received Date  July 19, 2005
Last Updated Date September 5, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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