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Trial record 2 of 5 for:    11790215 [PUBMED-IDS]

Insulin Resistance and Testosterone in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123110
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
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.
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Insulin Resistance
Postmenopause
Interventions Drug: metformin
Drug: leuprolide injection
Drug: placebo pill
Drug: placebo injection
Enrollment 35
Recruitment Details The participants were recruited beginning 8/11/05 and continued until the last patient was consented on 4/8/08.
Pre-assignment Details  
Arm/Group Title Metformin Leuprolide Placebo
Hide Arm/Group Description metformin plus leuprolide placebo (LP) injection leuprolide plus metformin placebo (MP) pill MP placebo pill plus LP placebo injection
Period Title: Overall Study
Started 12 12 11
Completed 12 12 11
Not Completed 0 0 0
Arm/Group Title Metformin Leuprolide Placebo Total
Hide Arm/Group Description metformin plus leuprolide placebo (LP) injection leuprolide plus metformin placebo (MP) pill MP placebo pill plus LP placebo injection Total of all reporting groups
Overall Number of Baseline Participants 12 12 11 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 11 participants 35 participants
56  (4) 58  (7) 62  (7) 58  (7)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 12 participants 12 participants 11 participants 35 participants
12 12 11 35
1.Primary Outcome
Title Percent Change in Free Testosterone (T)
Hide Description Percent change in free T by equilibrium dialysis between baseline and 12 weeks
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Leuprolide Placebo
Hide Arm/Group Description:
Randomized to metformin plus leuprolide placebo, treating insulin resistance
Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone
Placebo metformin plus placebo leuprolide
Overall Number of Participants Analyzed 12 12 11
Mean (Standard Deviation)
Unit of Measure: percent change
-6.9  (22.8) -35.8  (31.8) 12.1  (17.8)
2.Primary Outcome
Title Change in Insulin Sensitivity
Hide Description Change in insulin sensitivity (mg/kg/min) calculated from hyperinsulinemic euglycemic clamp
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Leuprolide Placebo
Hide Arm/Group Description:
Randomized to metformin plus leuprolide placebo, treating insulin resistance
Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone
Placebo metformin plus placebo leuprolide
Overall Number of Participants Analyzed 12 12 11
Mean (Standard Deviation)
Unit of Measure: mg/kg/min
0.44  (0.80) 0.04  (0.81) -0.08  (0.73)
3.Secondary Outcome
Title Percent Change in Luteinizing Hormone (LH) From Baseline
Hide Description [Not Specified]
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Leuprolide Placebo
Hide Arm/Group Description:
Randomized to metformin plus leuprolide placebo, treating insulin resistance
Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone
Placebo metformin plus placebo leuprolide
Overall Number of Participants Analyzed 12 12 11
Median (Full Range)
Unit of Measure: percent change
4.6
(-5.6 to 9.8)
-96.5
(-210.2 to -46.3)
-1.2
(-3.9 to 6.6)
4.Secondary Outcome
Title Percent Change in Homeostasis Model Assessment Index of Insulin Resistance (HOMA-IR)
Hide Description Insulin resistance calculated from homeostasis model assessment of insulin resistance (HOMA-IR) equation: fasting insulin x fasting glucose / 405. Higher values indicate more insulin resistance.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Leuprolide Placebo
Hide Arm/Group Description:
Randomized to metformin plus leuprolide placebo, treating insulin resistance
Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone
Placebo metformin plus placebo leuprolide
Overall Number of Participants Analyzed 12 12 11
Mean (Standard Deviation)
Unit of Measure: percent change
-31.0  (24.39) -8.18  (35.3) 4.67  (38.16)
5.Secondary Outcome
Title Percent Change in Low Density Lipoprotein (LDL)
Hide Description [Not Specified]
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Leuprolide Placebo
Hide Arm/Group Description:
Randomized to metformin plus leuprolide placebo, treating insulin resistance
Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone
Placebo metformin plus placebo leuprolide
Overall Number of Participants Analyzed 12 12 11
Mean (Standard Deviation)
Unit of Measure: percent change
-10.8  (22.2) 5.3  (19.3) 25.3  (50.8)
6.Secondary Outcome
Title Percent Change in Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Leuprolide Placebo
Hide Arm/Group Description:
Randomized to metformin plus leuprolide placebo, treating insulin resistance
Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone
Placebo metformin plus placebo leuprolide
Overall Number of Participants Analyzed 12 12 11
Mean (Standard Deviation)
Unit of Measure: percent change
-4.2  (8.6) 4.0  (13.6) -0.3  (8.6)
7.Secondary Outcome
Title Free T and IR in Women in Whom Metabolic Syndrome is Present vs. Absent
Hide Description [Not Specified]
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and the outcome will never be analyzed.
Arm/Group Title Metformin Leuprolide Placebo
Hide Arm/Group Description:
Randomized to metformin plus leuprolide placebo, treating insulin resistance
Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone
Placebo metformin plus placebo leuprolide
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Dehydroepiandrosterone Sulfate (DHEA-S)
Hide Description [Not Specified]
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Leuprolide Placebo
Hide Arm/Group Description:
Randomized to metformin plus leuprolide placebo, treating insulin resistance
Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone
Placebo metformin plus placebo leuprolide
Overall Number of Participants Analyzed 12 12 11
Median (Full Range)
Unit of Measure: percent change
2.6
(-10.5 to 18.4)
0.9
(-15.5 to 21.1)
-2.9
(-17.2 to 8.8)
9.Secondary Outcome
Title Body Mass Index (BMI)
Hide Description [Not Specified]
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Leuprolide Placebo
Hide Arm/Group Description:
Randomized to metformin plus leuprolide placebo, treating insulin resistance
Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone
Placebo metformin plus placebo leuprolide
Overall Number of Participants Analyzed 12 12 11
Mean (Standard Deviation)
Unit of Measure: percent change
-1.3  (3.2) 0.1  (1.5) 0.3  (1.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin Leuprolide Placebo
Hide Arm/Group Description metformin plus leuprolide placebo (LP) injection leuprolide plus metformin placebo (MP) pill MP placebo pill plus LP placebo injection
All-Cause Mortality
Metformin Leuprolide Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Metformin Leuprolide Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin Leuprolide Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne R. Cappola, M.D., ScM
Organization: University of Pennsylvania, School of Medicine
Phone: (215) 573-5359
EMail: ACappola@mail.med.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00123110     History of Changes
Other Study ID Numbers: AG0031
K23AG019161 ( U.S. NIH Grant/Contract )
K23AG1916101A1 ( Other Grant/Funding Number: NIA )
5P30DK019525 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2005
First Posted: July 22, 2005
Results First Submitted: January 16, 2013
Results First Posted: May 23, 2019
Last Update Posted: May 23, 2019