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Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Hypoleptinemia
Generalized Lipodystrophy
Partial Lipodystrophy
Insulin Resistance
Interventions Drug: Leptin
Drug: Placebo
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Leptin Therapy Placebo
Hide Arm/Group Description Randomized to Leptin Therapy for 4 months. Randomized to Placebo for 4 months.
Period Title: Overall Study
Started 13 12
Completed 10 9
Not Completed 3 3
Arm/Group Title Leptin Therapy Placebo Total
Hide Arm/Group Description Participants were randomized to receive Leptin . Participants were randomized to receive Placebo . Total of all reporting groups
Overall Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants
27.2  (11.9) 24.9  (13) 26.1  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
10
  76.9%
9
  75.0%
19
  76.0%
Male
3
  23.1%
3
  25.0%
6
  24.0%
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 13 participants 12 participants 25 participants
65.5  (17.5) 57.7  (16.0) 61.8  (16.9)
Fasting serum Triglycerides  
Median (Full Range)
Unit of measure:  mg/dL
Number Analyzed 13 participants 12 participants 25 participants
309.3
(69.3 to 1096.7)
443.8
(104.7 to 3556.3)
309.3
(69.3 to 3556.3)
Fasting serum Glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 13 participants 12 participants 25 participants
157.0  (74.2) 184.0  (87.2) 170.0  (80.2)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  % of haemoglobin
Number Analyzed 13 participants 12 participants 25 participants
8.1  (2.5) 8.0  (2.5) 8.0  (2.5)
1.Primary Outcome
Title Fasting Serum Triglycerides
Hide Description [Not Specified]
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leptin Therapy Placebo
Hide Arm/Group Description:
Randomized to Leptin Therapy for 4 months.
Randomized to Placebo for 4 months.
Overall Number of Participants Analyzed 10 9
Median (Full Range)
Unit of Measure: mg/dL
203
(100 to 457)
304
(129 to 3875)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Leptin Therapy, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2572
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title HbA1c
Hide Description [Not Specified]
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leptin Therapy Placebo
Hide Arm/Group Description:
Randomized to Leptin Therapy for 4 months.
Randomized to Placebo for 4 months.
Overall Number of Participants Analyzed 10 9
Median (Full Range)
Unit of Measure: % of haemoglobin
8.1
(5 to 12)
7.6
(5.1 to 11.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Leptin Therapy, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Fasting Serum Glucose
Hide Description [Not Specified]
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leptin Therapy Placebo
Hide Arm/Group Description:
Randomized to Leptin Therapy for 4 months.
Randomized to Placebo for 4 months.
Overall Number of Participants Analyzed 10 9
Median (Full Range)
Unit of Measure: mg/dL
162
(77 to 310)
165
(77 to 327)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Leptin Therapy, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Body Weight
Hide Description [Not Specified]
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leptin Therapy Placebo
Hide Arm/Group Description:
Randomized to Leptin Therapy for 4 months.
Randomized to Placebo for 4 months.
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: kg
62.5  (17.5) 56.3  (17.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Leptin Therapy, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0256
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 4 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Leptin Therapy Placebo
Hide Arm/Group Description Randomized to Leptin Therapy for 4 months. Randomized to Placebo for 4 months.
All-Cause Mortality
Leptin Therapy Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
Leptin Therapy Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Leptin Therapy Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      4/12 (33.33%)    
Blood and lymphatic system disorders     
Pneumonia * [1]  0/13 (0.00%)  0 1/12 (8.33%)  1
Eye disorders     
Blurry Vision and Epigastric pain *  0/13 (0.00%)  0 1/12 (8.33%)  1
General disorders     
Headaches * [2]  1/13 (7.69%)  13 0/12 (0.00%)  0
Infections and infestations     
viral illness, sinusitis, backache *  1/13 (7.69%)  1 0/12 (0.00%)  0
Surgical and medical procedures     
Tonsillectomy *  0/13 (0.00%)  0 1/12 (8.33%)  1
Right Ankle Pain *  0/13 (0.00%)  0 1/12 (8.33%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Pneumonia twice. Went To ER and took oral antibiotics
[2]
Nausea and cramps
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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. Abhimanyu Garg
Organization: UT Southwestern Medical Center
Phone: 214-648-2895
EMail: abhimanyu.garg@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Abhimanyu Garg, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00896298    
Other Study ID Numbers: 0502-294
First Submitted: May 8, 2009
First Posted: May 11, 2009
Results First Submitted: January 15, 2019
Results First Posted: March 5, 2019
Last Update Posted: April 2, 2019