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:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Abhimanyu Garg, University of Texas Southwestern Medical Center
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Leptin Therapy | Placebo |
---|---|---|
![]() |
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 |
Baseline Characteristics
Arm/Group Title | Leptin Therapy | Placebo | Total | |
---|---|---|---|---|
![]() |
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 | |
![]() |
[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) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Abhimanyu Garg |
Organization: | UT Southwestern Medical Center |
Phone: | 214-648-2895 |
EMail: | abhimanyu.garg@utsouthwestern.edu |
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 |