Novel Therapies for Metabolic Complications of Lipodystrophies
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|ClinicalTrials.gov Identifier: NCT00457938|
Recruitment Status : Unknown
Verified June 2013 by Abhimanyu Garg, University of Texas Southwestern Medical Center.
Recruitment status was: Recruiting
First Posted : April 9, 2007
Last Update Posted : June 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance Hypertriglyceridemia Diabetes Hepatic Steatosis||Other: low-fat diet ( Still recruiting ) Other: Diet||Phase 2 Phase 3|
We propose novel therapeutic approaches for the management of metabolic complications in patients with lipodystrophies. The four interventions to be tested are:
Hypothesis 1: An extremely low fat diet. Hypothesis 2: Leptin replacement therapy. Hypothesis 3: Cholic acid therapy.. Hypothesis 4: Peroxisome proliferator activated receptors (PPAR) agonist, pioglitazone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Novel Therapies for Metabolic Complications in Patients With Lipodystrophies|
|Study Start Date :||April 2006|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: Low fat diet is the "drug"
Diet 10% fat versus 35% fat
Other: low-fat diet ( Still recruiting )
This study will compare 10% fat versus 35% fat diets in terms if effect on liver fat, triglycerides adn other metabolic parameters.
Other Name: Low fat versus extremely low fat Diet
10 % versus 35 % fat in diet
- Project specific: improvement in serum triglycerides, insulin resistance, liver triglyceride content, liver volume, Hgb A1c, [ Time Frame: 6 to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457938
|Contact: Claudia Quittner, RN, BSN, MSfirstname.lastname@example.org|
|Contact: Zahid Ahmad, MDemail@example.com|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Claudia Quittner, RN, BSN, MS 214-648-9296 firstname.lastname@example.org|
|Contact: Zahid Ahmad, M.D. 214-648-2377 email@example.com|
|Principal Investigator: Abhimanyu Garg, M.D.|
|Sub-Investigator: Zahid Ahmad, M.D.|
|Principal Investigator:||Abhimanyu Garg, MD||UT Southwestern Medical Center|