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Leptin in the Maintenance of Reduced Body Weight

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01155180
First received: June 16, 2010
Last updated: February 22, 2017
Last verified: February 2017
Results First Received: December 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Obesity
Interventions: Drug: Leptin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects who have successfully completed 1of the 4 hospital-based participating weight loss programs (Boston Medical Center, Tufts Medical Center, Massachusetts General Hospital, Beth Israel Deaconess Medical Center (BIDMC)-Joslin Center) & have achieved a >8% (average 10%, range 8-14%) weight loss will be invited to participate in the study.

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
Leptin

We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Leptin: Hormone - daily self injections for 6 months

Placebo

We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Placebo: Placebo


Participant Flow:   Overall Study
    Leptin   Placebo
STARTED   18   6 
COMPLETED   18   6 
NOT COMPLETED   0   0 



  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
Leptin

We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Leptin: Hormone - daily self injections for 6 months

Placebo

We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Placebo: Placebo-daily self injections for 6 months

Total Total of all reporting groups

Baseline Measures
   Leptin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   6   24 
Age, Customized 
[Units: Years]
Mean (Full Range)
     
years   32 
 (23 to 41) 
 45.5 
 (24 to 67) 
 45 
 (23 to 67) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  50.0%      6 100.0%      15  62.5% 
Male      9  50.0%      0   0.0%      9  37.5% 
Region of Enrollment 
[Units: Participants]
     
United States   18   6   24 


  Outcome Measures

1.  Primary:   Percent Change From Baseline in Body Weight at 6 Months   [ Time Frame: baseline and 6 months after randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
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  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 Manztoros
Organization: Beth Israel Deaconess Medical Center
phone: 617-667-8630
e-mail: cmantzor@bidmc.harvard.edu



Responsible Party: Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01155180     History of Changes
Other Study ID Numbers: 2008P000190
R01DK079929 ( U.S. NIH Grant/Contract )
Study First Received: June 16, 2010
Results First Received: December 22, 2015
Last Updated: February 22, 2017