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Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00140244
First Posted: September 1, 2005
Last Update Posted: May 11, 2017
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.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Amgen
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center
Results First Submitted: December 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: HAART-induced Lipodystrophy and Metabolic Syndrome
Interventions: Drug: r-metHuLeptin
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
r-MetHuLeptin First, Then Placebo r-MetHuLeptin subcutaneously once daily first, then Placebo both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
Placebo First, Then r-metHuLeptin Subcutaneously once daily Placebo first, then r-metHuLeptin both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.

Participant Flow for 3 periods

Period 1:   Intervention 1
    r-MetHuLeptin First, Then Placebo   Placebo First, Then r-metHuLeptin
STARTED   3   4 
COMPLETED   3   4 
NOT COMPLETED   0   0 

Period 2:   Washout
    r-MetHuLeptin First, Then Placebo   Placebo First, Then r-metHuLeptin
STARTED   3   4 
COMPLETED   3   4 
NOT COMPLETED   0   0 

Period 3:   Intervention 2
    r-MetHuLeptin First, Then Placebo   Placebo First, Then r-metHuLeptin
STARTED   3   4 
COMPLETED   3   2 
NOT COMPLETED   0   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants

r-MetHuLeptin SubQ once daily

r-metHuLeptin/placebo then placebo/r-metHuLeptin


Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      7 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.8  (2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      7 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   7 
Body mass index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 22.2  (0.83) 
Fasting leptin concentration 
[Units: Ng/ml]
Mean (Standard Deviation)
 1.34  (0.2) 
triglycerides 
[Units: Mg/dl]
Mean (Standard Deviation)
 530  (53.8) 
insulin 
[Units: Micro international units(μIU)/ml]
Mean (Standard Deviation)
 11.5  (2.7) 
glucose 
[Units: Mg/dl]
Mean (Standard Deviation)
 81.1  (6.7) 
hemoglobin A1c 
[Units: %]
Mean (Standard Deviation)
 5.1  (0.3) 
CD4 count 
[Units: Cells/μl]
Mean (Standard Deviation)
 454  (94) 
HIV viral load 
[Units: Copies/ml]
Mean (Standard Deviation)
 24524  (13693) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Serum Lipid Levels   [ Time Frame: At the end of each two month intervention ]

2.  Secondary:   Insulin Resistance (as Assessed by HOMA-IR)   [ Time Frame: At the end of each two month intervention ]

3.  Secondary:   Glycemia (as Assessed by Fasting Glucose)   [ Time Frame: At the end of each two month intervention ]

4.  Secondary:   Low Density Lipoprotein (LDL) Cholesterol Levels   [ Time Frame: At the end of each two month intervention ]

5.  Secondary:   Free Fatty Acid (FFA) Levels   [ Time Frame: At the end of each two month intervention ]

6.  Secondary:   Blood Pressure   [ Time Frame: At the end of each two month intervention ]

7.  Secondary:   Fibrinogen   [ Time Frame: At the end of each two month intervention ]

8.  Secondary:   Insulin Levels   [ Time Frame: At the end of each two month intervention ]

9.  Secondary:   Lean Body Mass   [ Time Frame: At the end of each two month intervention ]

10.  Secondary:   Viral Load   [ Time Frame: At the end of each two month intervention ]

11.  Secondary:   CD4+ Lymphocytes   [ Time Frame: At the end of each two month intervention ]

12.  Secondary:   Interleukin-6 (IL-6) Levels   [ Time Frame: At the end of each two month intervention ]

13.  Secondary:   Hepatic Fat Content   [ Time Frame: At the end of each two month intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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:  
Name/Title: Dr. Christos Mantzoros
Organization: BIDMC
phone: 617-667-8630
e-mail: cmantzor@bidmc.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00140244     History of Changes
Other Study ID Numbers: 2001P000484
R01DK058785 ( U.S. NIH Grant/Contract )
First Submitted: August 30, 2005
First Posted: September 1, 2005
Results First Submitted: December 22, 2015
Results First Posted: April 6, 2017
Last Update Posted: May 11, 2017