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Sponsors and Collaborators: |
National Institute on Aging (NIA) 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. |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00123110 |
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.
Condition | Intervention | Phase |
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Insulin Resistance Postmenopause |
Drug: metformin Drug: leuprolide acetate Drug: placebo pill Drug: placebo injection |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Insulin Resistance and Testosterone in Non-Diabetic Postmenopausal Women |
Enrollment: | 36 |
Study Start Date: | July 2005 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
metformin plus placebo injection
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Drug: metformin
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
Drug: placebo injection
matching injection every 4 weeks (e.g. baseline, 4, and 8 weeks)
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2: Experimental
leuprolide plus placebo pill
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Drug: leuprolide acetate
3.75 mg injection every 4 weeks (e.g. at baseline, 4, and 8 weeks)
Drug: placebo pill
matching pill twice a day for 12 weeks
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3: Placebo Comparator
placebo pill plus placebo injection
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Drug: placebo pill
matching pill twice a day for 12 weeks
Drug: placebo injection
matching injection every 4 weeks (e.g. baseline, 4, and 8 weeks)
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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.
Ages Eligible for Study: | 50 Years to 79 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Clinical and Translational Research Center, University of Pennsylvania School of Medicine | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Anne R. Cappola, MD, ScM | University of Pennsylvania |
Responsible Party: | University of Pennsylvania School of Medicine ( Anne R. Cappola, MD, ScM ) |
Study ID Numbers: | AG0031, K23AG1916101A1, 5P30DK019525 |
Study First Received: | July 19, 2005 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00123110 |
Health Authority: | United States: Federal Government |
Hyperinsulinism Testosterone Metabolic Diseases Leuprolide Metformin Methyltestosterone |
Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Insulin Testosterone 17 beta-cypionate |
Antineoplastic Agents, Hormonal Antineoplastic Agents Fertility Agents, Female Therapeutic Uses Fertility Agents Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Pharmacologic Actions Androgens |