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Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome

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: NCT00362440
Recruitment Status : Completed
First Posted : August 10, 2006
Results First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV Lipodystrophy
Interventions Drug: Leptin
Drug: Pioglitazone or metformin
Drug: Placebo
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Leptin Pioglitazone or Metformin
Hide Arm/Group Description

Leptin replacement therapy

Leptin+pioglitazone

Diabetes treatment therapy

Pioglitazone+placebo
Period Title: Overall Study
Started 5 4
Completed 3 3
Not Completed 2 1
Arm/Group Title Leptin Pioglitazone or Metformin Total
Hide Arm/Group Description

Leptin replacement therapy

Leptin+pioglitazone

Diabetes treatment therapy

Pioglitazone+placebo

 Total of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
4
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 9 participants
50
(43 to 57)
50
(43 to 57)
50
(43 to 57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
5
 100.0%
4
 100.0%
9
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 4 participants 9 participants
5 4 9
1.Primary Outcome
Title Insulin Resistance (HOMA Index)
Hide Description [Not Specified]
Time Frame At the end of each 3 month intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leptin Pioglitazone or Metformin
Hide Arm/Group Description:

Leptin replacement therapy

Leptin+pioglitazone

Diabetes treatment therapy

Pioglitazone+placebo
Overall Number of Participants Analyzed 5 4
Mean (Standard Error)
Unit of Measure: units on a scale
1.6  (0.5) 1.8  (0.8)
2.Secondary Outcome
Title Cholesterol Levels
Hide Description [Not Specified]
Time Frame At the end of each 3 month intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leptin Pioglitazone or Metformin
Hide Arm/Group Description:

Leptin replacement therapy

Leptin+pioglitazone

Diabetes treatment therapy

Pioglitazone+placebo
Overall Number of Participants Analyzed 5 4
Mean (Standard Error)
Unit of Measure: mg/dl
190  (13) 183  (17)
3.Secondary Outcome
Title Body Composition (Fat Mass)
Hide Description [Not Specified]
Time Frame At the end of each 3 month intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leptin Pioglitazone or Metformin
Hide Arm/Group Description:

Leptin replacement therapy

Leptin+pioglitazone

Diabetes treatment therapy

Pioglitazone+placebo
Overall Number of Participants Analyzed 5 4
Mean (Standard Error)
Unit of Measure: kg
16.7  (1.7) 13.1  (0.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Leptin Pioglitazone or Metformin
Hide Arm/Group Description

Leptin replacement therapy

Leptin+pioglitazone

Diabetes treatment therapy

Pioglitazone+placebo
All-Cause Mortality
Leptin Pioglitazone or Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Leptin Pioglitazone or Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/4 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Leptin Pioglitazone or Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      1/4 (25.00%)    
Skin and subcutaneous tissue disorders     
Injection site reaction  1/5 (20.00%)  1 1/4 (25.00%)  1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christos Mantzoros
Organization: BIDMC
Phone: 617-667-8630
EMail: cmantzor@bidmc.harvard.edu
Publications:
Layout table for additonal information
Responsible Party: Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00362440    
Other Study ID Numbers: 2005P000159
First Submitted: August 9, 2006
First Posted: August 10, 2006
Results First Submitted: December 22, 2015
Results First Posted: March 23, 2017
Last Update Posted: March 23, 2017