View Clinical Trial (Medical Research Study)
Novel Therapies for Metabolic Complications in Patients With Lipodystrophies
| City: |
|
Dallas |
| State: |
|
Texas |
| Zip Code: |
|
75390 |
| Conditions: |
|
Insulin Resistance - Hypertriglyceridemia - Diabetes - Hepatic Steatosis |
| Purpose: |
|
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.
|
| Study Summary: |
|
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. Hypothesis 2: Leptin replacement therapy.
Hypothesis 3: Cholic acid therapy.. Hypothesis 4: Peroxisome proliferator activated
receptors (PPAR) agonist, pioglitazone.
|
| 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
|
| NCT ID: |
|
NCT00457938 |
| Primary Contact: |
|
Principal Investigator
Abhimanyu Garg, MD
UT Southwestern Medical Center
Claudia Quittner, RN, BSN, MS
Phone: 214-648-9296
Email: claudia.quittner@utsouthwestern.edu
|
| Backup Contact: |
|
Email: zahid.ahmad@utsouthwestern.edu
Zahid Ahmad, MD
Phone: 214-648-2377
|
| Location Contact: |
|
Dallas, Texas 75390
United States
Claudia Quittner, RN, BSN, MS
Phone: 214-648-9296
Email: claudia.quittner@utsoutwestern.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 24, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|