Back to resultsNovel Therapies for Metabolic Complications of Lipodystrophies
Primary Purpose
Insulin Resistance, Hypertriglyceridemia, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low-fat diet ( Still recruiting )
Diet
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring lipodystrophy
Eligibility Criteria
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
Sites / Locations
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Low fat diet is the "drug"
Arm Description
Diet 10% fat versus 35% fat
Outcomes
Primary Outcome Measures
Project specific: improvement in serum triglycerides, insulin resistance, liver triglyceride content, liver volume, Hgb A1c,
Secondary Outcome Measures
Full Information
NCT ID
NCT00457938
First Posted
April 4, 2007
Last Updated
October 11, 2018
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institutes of Health (NIH), Takeda, Amylin Pharmaceuticals, LLC.
1. Study Identification
Unique Protocol Identification Number
NCT00457938
Brief Title
Novel Therapies for Metabolic Complications of Lipodystrophies
Official Title
Novel Therapies for Metabolic Complications in Patients With Lipodystrophies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institutes of Health (NIH), Takeda, Amylin Pharmaceuticals, LLC.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 diet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Hypertriglyceridemia, Diabetes, Hepatic Steatosis
Keywords
lipodystrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low fat diet is the "drug"
Arm Type
Other
Arm Description
Diet 10% fat versus 35% fat
Intervention Type
Other
Intervention Name(s)
low-fat diet ( Still recruiting )
Other Intervention Name(s)
Low fat versus extremely low fat Diet
Intervention Description
This study will compare 10% fat versus 35% fat diets in terms if effect on liver fat, triglycerides adn other metabolic parameters.
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
10 % versus 35 % fat in diet
Primary Outcome Measure Information:
Title
Project specific: improvement in serum triglycerides, insulin resistance, liver triglyceride content, liver volume, Hgb A1c,
Time Frame
6 to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhimanyu Garg, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22170723
Citation
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.
Results Reference
derived
Learn more about this trial
Novel Therapies for Metabolic Complications of Lipodystrophies
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