Novel Therapies for Metabolic Complications of Lipodystrophies

Diabetes Clinical Trial

Official title:

Novel Therapies for Metabolic Complications in Patients With Lipodystrophies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457938
• Other study ID #: RO1-074959
• Secondary ID: DK074959
• Status: Completed
• Phase: N/A
• Start date: April 2006
• Est. completion date: November 2014

Study information

• Verified date: October 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Fatty Liver
• Hepatic Steatosis
• Hypertriglyceridemia
• Insulin Resistance
• Lipodystrophy

Intervention

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.
• Diet
10 % versus 35 % fat in diet

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (4)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Amylin Pharmaceuticals, LLC., National Institutes of Health (NIH), Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Project specific: improvement in serum triglycerides, insulin resistance, liver triglyceride content, liver volume, Hgb A1c,		6 to 12 months