Status:
COMPLETED
Novel Therapies for Metabolic Complications of Lipodystrophies
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Takeda
Conditions:
Insulin Resistance
Hypertriglyceridemia
Eligibility:
All Genders
14-70 years
Phase:
NA
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 ...
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 die...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00457938
Start Date
April 1 2006
End Date
November 1 2014
Last Update
October 16 2018
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390