Novel Therapies for Metabolic Complications of Lipodystrophies

Not Applicable

Completed

• Conditions: Insulin Resistance; Diabetes; Hepatic Steatosis; Hypertriglyceridemia
• Interventions: Other: low-fat diet ( Still recruiting ); Other: Diet

• Registration Number: NCT00457938
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-06
• Study First Posted: 2007-04-09
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low fat diet is the "drug"	low-fat diet ( Still recruiting )	Diet 10% fat versus 35% fat
Low fat diet is the "drug"	Diet	Diet 10% fat versus 35% fat

Primary Outcome Measures

Name	Time	Method
Project specific: improvement in serum triglycerides, insulin resistance, liver triglyceride content, liver volume, Hgb A1c,	6 to 12 months

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States