Novel Therapies for Metabolic Complications of Lipodystrophies

NCT00457938 | Completed DMC

• 2 other identifiers: RO1-074959DK074959
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Hypertriglyceridemia; Diabetes; Hepatic Steatosis

Keywords

lipodystrophy

Outcome Measures

Primary Outcomes (1)

• Project specific: improvement in serum triglycerides, insulin resistance, liver triglyceride content, liver volume, Hgb A1c,

  6 to 12 months

Study Arms (1)

Low fat diet is the "drug"

OTHER

Diet 10% fat versus 35% fat

Other: low-fat diet ( Still recruiting ); Other: Diet

Interventions

low-fat diet ( Still recruiting ) OTHER

This study will compare 10% fat versus 35% fat diets in terms if effect on liver fat, triglycerides adn other metabolic parameters.

Also known as: Low fat versus extremely low fat Diet

Low fat diet is the "drug"

Diet OTHER

10 % versus 35 % fat in diet

Low fat diet is the "drug"

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institutes of Health (NIH): collaborator
• Takeda: collaborator
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Simha V, Subramanyam L, Szczepaniak L, Quittner C, Adams-Huet B, Snell P, Garg A. Comparison of efficacy and safety of leptin replacement therapy in moderately and severely hypoleptinemic patients with familial partial lipodystrophy of the Dunnigan variety. J Clin Endocrinol Metab. 2012 Mar;97(3):785-92. doi: 10.1210/jc.2011-2229. Epub 2011 Dec 14.

  PMID: 22170723 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Hypertriglyceridemia; Diabetes Mellitus; Fatty Liver; Lipodystrophy

Interventions

Diet, Fat-Restricted; Diet

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Endocrine System Diseases; Liver Diseases; Digestive System Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Abhimanyu Garg, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Division Nutrition and Metabolic Diseases, Professor Internal Medicine

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 9, 2007
• Study Start: April 1, 2006
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

US (1)