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Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

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: NCT00896298
Recruitment Status : Completed
First Posted : May 11, 2009
Results First Posted : March 5, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Abhimanyu Garg, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE May 8, 2009
First Posted Date  ICMJE May 11, 2009
Results First Submitted Date  ICMJE January 15, 2019
Results First Posted Date  ICMJE March 5, 2019
Last Update Posted Date April 2, 2019
Study Start Date  ICMJE April 2006
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
  • Fasting Serum Triglycerides [ Time Frame: 4 months ]
  • HbA1c [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2009)
Project Specific: to determine if r-metHuLeptin can be safely replaced in hypoleptinemic patients with generalized and partial lipodystrophies. [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
  • Fasting Serum Glucose [ Time Frame: 4 months ]
  • Body Weight [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2009)
Project Specific: to determine if r-metHuLeptin administration is effective in improving glucose and lipid abnormalities in hypoleptinemic patients with generalized and partial lipodystrophies. [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Leptin Replacement Therapy in Patients With Lipodystrophy
Official Title  ICMJE Double-Blind, Placebo-Controlled Trial of Leptin Replacement Therapy in Patients With Lipodystrophy
Brief Summary Lipodystrophies represent a therapeutic challenge with regards to insulin resistance, hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects with lipodystrophy.
Detailed Description

The mechanism by which leptin improves glucose and lipid control is not clear. We will examine the possible mechanisms of leptin action by studying the effects of leptin administration on food intake, insulin resistance, insulin secretory response, hepatic and intramuscular triglyceride stores in a large sample of patients with lipodystrophy.

Hypothesis: Leptin replacement in patients with generalized and partial lipodystrophy and hypoleptinemia will be safe and efficacious in improving the metabolic abnormalities associated with insulin resistance.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypoleptinemia
  • Generalized Lipodystrophy
  • Partial Lipodystrophy
  • Insulin Resistance
Intervention  ICMJE
  • Drug: Leptin
    Leptin injected subcutaneously twice a day, to be administered at 100% of the estimated replacement dose during the first month, which is a dosage of 0.03mg/kg for female children, 0.04mg/kg for adult females, and0.02 mg/kg for all males, and then at 200% subsequently, or placebo.
    Other Names:
    • Recombinant-methionyl Human Leptin.
    • r-metHuLeptin
  • Drug: Placebo
    Sugar pill
Study Arms  ICMJE
  • Active Comparator: 1 Leptin
    Active Comparator for 4 months, then for 8 months.
    Intervention: Drug: Leptin
  • Placebo Comparator: 2 Sugar pill
    Placebo for 4 months, then active comparator for 8 months.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2019)
25
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2009)
24
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age > 6 years
  • Partial and generalized lipodystrophy
  • Serum leptin levels less than the 7th percentile of normal values reported by the 3rd National Health and Nutrition Examination survey (less than 7.0 ng/mL in females and less than 3/0 ng/mL in males)
  • Presence of at least one of the following metabolic abnormalities:

    1. Type 2 Diabetes Mellitus
    2. Fasting serum insulin >20 uU/mL
    3. Fasting serum triglycerides > 300 mg/dL
    4. Previous participation in leptin trial (Amgen 991265, GCRC 660) - for Part B of the Study.

Exclusion Criteria:

  • Known liver disease due to causes other than non-alcoholic steatohepatitis.
  • Hematocrit of less than 30%.
  • Current alcohol or substance abuse.
  • Use of anorexigenic drugs, anabolic steroids, GH and thiazolidinediones
  • Active tuberculosis
  • Psychiatric disorder impeding competence or compliance
  • Malignancies
  • HIV infection
  • Subjects who have a known hypersensitivity to E. Coli derived proteins
  • Other condition, which in the opinion of the clinical investigators would impede completion of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00896298
Other Study ID Numbers  ICMJE 0502-294
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abhimanyu Garg, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abhimanyu Garg, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP