Novel Therapies for Metabolic Complications of Lipodystrophies

This study is currently recruiting participants.
Verified June 2013 by University of Texas Southwestern Medical Center
Sponsor:
Collaborators:
Takeda
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Abhimanyu Garg, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00457938
First received: April 4, 2007
Last updated: June 19, 2013
Last verified: June 2013
  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 )
Other: Diet
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: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Diet
10 % versus 35 % fat in 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.    214-648-2377    zahid.ahmad@utsouthwestern.edu   
Principal Investigator: Abhimanyu Garg, M.D.         
Sub-Investigator: Zahid Ahmad, M.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Takeda
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: Abhimanyu Garg, Chairman, Division Nutrition and Metabolic Diseases, Professor Internal Medicine, University of Texas 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: June 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
lipodystrophy

Additional relevant MeSH terms:
Fatty Liver
Hypertriglyceridemia
Insulin Resistance
Lipodystrophy
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 April 21, 2014