Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.

NCT00186537 | Completed Results

• 2 other identifiers: 79301SPO 28829
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 1/4 of the US population has insulin resistance and the associated risk factors such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver produces and low HDL cholesterol which is the good cholesterol helping to protect against heart disease. Currently one known treatment for this a medication called fenofibrate, another medication that can improve insulin resistance is rosiglitazone, a third treatment known to improve insulin resistance an decrease triglycerides is weight loss. In this study insulin resistant individuals with elevated triglycerides and or a ratio of triglycerides to HDL cholesterol of 3:1 or greater will be randomized (selected by chance) to receive one of these treatments and results of insulin sensitivity and cardiac risk profiles will be compared at the end of the study.

Conditions

Insulin Resistance; Hypertriglyceridemia

Keywords

Insulin resistance; Insulin resistance syndrome; dyslipidemia; atherogenic dyslipidemia; triglyceride/HDL-C ratio

Outcome Measures

Primary Outcomes (3)

• Pre- and Post-Intervention Triglyceride Levels

  Compare the change in mean triglyceride levels between groups after the interventions

  Baseline, 12 weeks

• Pre- and Post-Intervention LDL Cholesterol Levels

  Compare the change in mean LDL Cholesterol levels between groups after the interventions

  Baseline, 12 weeks

• Pre- and Post-Intervention HDL Cholesterol Levels

  Compare the change in mean HDL Cholesterol levels between groups after the interventions

  Baseline, 12 weeks

Study Arms (3)

fenofibrate

ACTIVE COMPARATOR

160 mg daily for 12 weeks

Drug: Fenofibrate

rosiglitazone

ACTIVE COMPARATOR

4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks

Drug: Rosiglitazone

calorie restricted diet

ACTIVE COMPARATOR

calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks

Behavioral: Weight Loss

Interventions

Rosiglitazone DRUG

Also known as: avandia

rosiglitazone

Fenofibrate DRUG

Also known as: tricor

fenofibrate

Weight Loss BEHAVIORAL

calorie restricted diet

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Insulin Resistant Triglyceride 150 mg/dL or greater or triglyceride HDL-C ratio 3 or greater BMI 25-35

You may not qualify if:

• Diabetes Mellitus History of gall stones History of CHF History of CAD Severe anemia,kidney, or liver disease

Sponsors & Collaborators

• Stanford University: lead
• Abbott: collaborator

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Related Publications (3)

• Reaven GM. Banting lecture 1988. Role of insulin resistance in human disease. Diabetes. 1988 Dec;37(12):1595-607. doi: 10.2337/diab.37.12.1595.

  PMID: 3056758 BACKGROUND

• Laws A, Reaven GM. Evidence for an independent relationship between insulin resistance and fasting plasma HDL-cholesterol, triglyceride and insulin concentrations. J Intern Med. 1992 Jan;231(1):25-30. doi: 10.1111/j.1365-2796.1992.tb00494.x.

  PMID: 1732395 BACKGROUND

• Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002 Jan 16;287(3):356-9. doi: 10.1001/jama.287.3.356.

  PMID: 11790215 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance; Hypertriglyceridemia; Metabolic Syndrome; Dyslipidemias

Interventions

Rosiglitazone; Fenofibrate

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Results Point of Contact

• Title: Dr. Gerald Reaven
• Organization: Stanford University

greaven@stanford.edu

650-724-3416

Study Officials

• Gerald M Reaven, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2003
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 12, 2017
• Results First Posted: May 5, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)