Novel Therapies for Metabolic Complications of Lipodystrophies

The University of Texas System (UT)

Status

Completed

Conditions

Diabetes

Hypertriglyceridemia

Insulin Resistance

Hepatic Steatosis

Treatments

Other: low-fat diet ( Still recruiting )

Other: Diet

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00457938

DK074959

RO1-074959

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

14 to 70 years old

Volunteers

No Healthy Volunteers

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.