Trial record 10 of 15 for:
lipodystrophy and dallas
Novel Therapies for Metabolic Complications of Lipodystrophies
This study is currently recruiting participants.
Verified August 2011 by University of Texas Southwestern Medical Center
Sponsor:
University of Texas Southwestern Medical Center
Collaborators:
Takeda Global Research & Development Center, Inc.
Amylin Pharmaceuticals, LLC.
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00457938
First received: April 4, 2007
Last updated: August 2, 2011
Last verified: August 2011
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Purpose
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 |
|---|---|---|
|
Insulin Resistance Hypertriglyceridemia Diabetes Hepatic Steatosis |
Other: low-fat diet ( Still recruiting ) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Novel Therapies for Metabolic Complications in Patients With Lipodystrophies |
Resource links provided by NLM:
Further study details as provided by University of Texas Southwestern Medical Center:
Primary Outcome Measures:
- Project specific: improvement in serum triglycerides, insulin resistance, liver triglyceride content, liver volume, Hgb A1c, [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 72 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Low fat diet
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 14 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
General Inclusion criteria:
- Patients with lipodystrophies as diagnosed by clinical criteria
Any one of the following:
- Diabetes mellitus, or
- Fasting serum triglycerides greater than 200 mg/dL, or
- Fasting serum insulin greater than 30 U/mL, or
- Hepatic steatosis ( greater than 5.6% hepatic triglyceride content) as demonstrated by 1H MRS.
Exclusion Criteria:
- Known liver disease due to causes other than non-alcoholic steatohepatitis:
- Current alcohol abuse (more than 7 drinks or 210 g per wk for women and more than 14 drinks or 420 g per wk for men).
- Positive serological markers of hepatitis B and C.
- Autoimmune hepatitis, autoimmune cholestatic liver disorders, Wilson disease and Alpha-1-antitrypsin deficiency as indicated by clinical and laboratory tests.
- Drug-induced liver disease
- Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study suggestive of liver cancer.
- Decompensated liver disease as evidenced by clinical features of hepatic failure (variceal bleeding, ascites, hepatic encephalopathy etc.) and laboratory investigations (prolonged prothrombin time, hypoalbuminemia, presence of esophageal varices etc.)
- Use of the drugs which can potentially decrease hepatic steatosis during previous 3 months; high-dose vitamin E, betaine, acetylcysteine, choline and probucol.
- Significant systemic or major illnesses other than liver disease (congestive heart failure, unstable angina, cerebrovascular disease, respiratory failure, renal failure [serum creatinine more then 2 mg/dL], acute pancreatitis, organ transplantation, serious psychiatric disease, and malignancy) that could interfere with the trial and adequate follow up.
- Acute medical illnesses precluding participation in the studies.
- Known HIV infected patient.
- Current substance abuse.
- Pregnant or lactating women.
- Hematocrit of less than 30%.
- History of weight loss ( more than 10%) or use of weight loss drugs such as sibutramine or orlistat in the last 3 months.
Each subproject has additional specific inclusion and exclusion criteria
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457938
Contacts
| Contact: Claudia Quittner, RN, BSN, MS | 214-648-9296 | claudia.quittner@utsouthwestern.edu |
| Contact: Zahid Ahmad, MD | 214-648-2377 | zahid.ahmad@utsouthwestern.edu |
Locations
| 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: Zahid Ahmad, M.D. 214-648-0548 zahid.ahmad@utsouthwestern.edu | |
| Principal Investigator: Abhimanyu Garg, M.D. | |
| Sub-Investigator: Vinaya Simha, M.D. | |
| Sub-Investigator: Zahid Ahmad, M.D. | |
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Takeda Global Research & Development Center, Inc.
Amylin Pharmaceuticals, LLC.
Investigators
| Principal Investigator: | Abhimanyu Garg, MD | UT Southwestern Medical Center |
More Information
Additional Information:
No publications provided by University of Texas Southwestern Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Abhimanyu Garg, UT Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00457938 History of Changes |
| Other Study ID Numbers: | RO1-074959, DK074959 |
| Study First Received: | April 4, 2007 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Texas Southwestern Medical Center:
|
lipodystrophy |
Additional relevant MeSH terms:
|
Lipodystrophy Fatty Liver Hypertriglyceridemia Insulin Resistance Liver Diseases Digestive System Diseases Hyperlipidemias |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Hyperinsulinism Glucose Metabolism Disorders Skin Diseases, Metabolic Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013