Novel Therapies for Metabolic Complications of Lipodystrophies

Conditions:High Cholesterol, Endocrine, Gastrointestinal, Diabetes, Metabolic
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Gastroenterology, Pharmacology / Toxicology
Age Range:14 - 70
Start Date:April 2006
End Date:November 2014

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Novel Therapies for Metabolic Complications in Patients With Lipodystrophies

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.

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.

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
We found this trial at
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
Dallas, TX
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