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Sponsors and Collaborators: |
University of Texas Southwestern Medical Center National Institutes of Health (NIH) Takeda Global Research & Development Center, Inc. |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00457938 |
Lipodystrophies represent a therapeutic challenge with regards to the management of the diabetes, insulin resistance, hypertriglyceridemia and fatty liver which frequently present in conjunction with significant adipose tissue loss. The purpose of the study and it’s four subprojects is to examine the safety and efficacy of various novel interventions designed to improve or resolve the fatty liver, hypertriglyceridemia, and insulin resistance or diabetes that is seen in these patients.
Condition | Intervention | Phase |
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Insulin Resistance Hypertriglyceridemia Diabetes Hepatic Steatosis |
Drug: leptin Drug: pioglitazone Drug: cholic acid Behavioral: low-fat diet |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Novel Therapies for Metabolic Complications in Patients With Lipodystrophies |
Estimated Enrollment: | 72 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | August 2011 |
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.
Ages Eligible for Study: | 14 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
General Inclusion criteria:
Any one of the following:
Exclusion Criteria:
Each subproject has additional specific inclusion and exclusion criteria
Contact: Claudia Quittner, RN, BSN, MS | 214-648-9296 | claudia.quittner@utsouthwestern.edu |
Contact: Lalitha Subramnayam, MD | 214-648-4773 | lalitha.subramanyam@utsouthwestern.edu |
United States, Texas | |
UT Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Claudia Quittner, RN, BSN, MS 214-648-9296 claudia.quittner@utsoutwestern.edu | |
Contact: Lalitha Subramanyam, M.D. 214-648-4773 lalitha.subramanyam@utsouthwestern.edu | |
Principal Investigator: Abhimanyu Garg, M.D. | |
Sub-Investigator: Vinaya Simha, M.D. | |
Sub-Investigator: Lalitha Subrammanyam, M.D. |
Principal Investigator: | Abhimanyu Garg, MD | UT Southwestern Medical Center |
Study ID Numbers: | RO1-074959, DK074959 |
Study First Received: | April 4, 2007 |
Last Updated: | April 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00457938 |
Health Authority: | United States: Food and Drug Administration |
lipodystrophy |
Liver Diseases Hypertriglyceridemia Hyperlipidemias Metabolic Diseases Pioglitazone Skin Diseases Diabetes Mellitus Fatty Liver Cholic Acids |
Hyperinsulinism Digestive System Diseases Lipodystrophy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Dyslipidemias Lipid Metabolism Disorders |
Hypoglycemic Agents Skin Diseases, Metabolic Therapeutic Uses |
Physiological Effects of Drugs Gastrointestinal Agents Pharmacologic Actions |