Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL)

This study has been terminated.
(Slow recruitment and increase in deployment overseas limiting follow up)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Ahmad Slim, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00819910
First received: January 8, 2009
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

The design of the study will be randomized, double blind trial, which will examine the effects of Rosiglitazone on the fasting triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and plasma concentrations of apolipoproteins A-I, A-II, and C-III as compared to Fenofibrate and placebo. This study will also assess the synergistic effect of Rosiglitazone and Fenofibrate on the same parameters. Data from this study will help clarify whether Rosiglitazone favorably impacts plasma lipid and lipoprotein concentrations through improving insulin sensitivity and glycemic control, or by directly influencing the synthesis of the apolipoproteins that are responsible for very-low-density lipoprotein (VLDL) and HDL metabolism.


Condition Intervention Phase
Hypertriglyceridemia in Type 4 Hyperlipidemia
Non Diabetic Subjects With Normoglycemia
Drug: Rosiglitazone
Drug: Placebo (Rosiglitazone)
Drug: Placebo (Fenofibrate)
Drug: Fenofibrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL)

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • Percent Change in Triglyceride (TG) Levels Post Treatment [ Time Frame: 12 weeks from initial visit (day 0) to final visit (12 weeks) ] [ Designated as safety issue: No ]
    The reported percent change is the difference between TG levels obtained on initial visit (day 0) and TG levels obtained at final visit (week 12) as per protocol


Secondary Outcome Measures:
  • Post-treatment Percent Change in High-Density Lipoprotein (HDL) Levels [ Time Frame: 12 weeks from initial visit (day 0) to final visit (12 weeks) ] [ Designated as safety issue: No ]
    The reported percent change is the difference between HDL levels obtained on initial visit (day 0) and HDL levels obtained at final visit (week 12) as per protocol

  • Post-treatment Percent Change in Low-Density Lipoprotein (LDL) Levels [ Time Frame: 12 weeks from initial visit (day 0) to final visit (12 weeks) ] [ Designated as safety issue: No ]
    The reported percent change is the difference between LDL levels obtained on initial visit (day 0) and LDL levels obtained at final visit (week 12) as per protocol

  • Post-treatment Percent Change in Apolipoprotein A-I (Apo AI), Apolipoprotein A-II (Apo AII) and Apolipoprotein C-III (Apo CIII) Levels [ Time Frame: 12 weeks from initial visit (day 0) to final visit (12 weeks) ] [ Designated as safety issue: No ]
    Post-treatment median change in Apo AI, Apo AII and Apo CIII levels reported in mg/dL with Interquartile ranges provided

  • Mean Levels of Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Initial Visit and Final Visit [ Time Frame: 12 weeks from initial visit (day 0) to final visit (12 weeks) ] [ Designated as safety issue: Yes ]
    The mean Levels of AST and ALT measured at initial visit (Day 0) and final visit (Week 12) annotated as AST 1, AST 12, and ALT 1 and ALT 12, respectively.


Enrollment: 41
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rosiglitazone + Placebo
Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
Drug: Rosiglitazone
Rosiglitazone 8mg daily for 12 weeks
Other Name: Avandia
Drug: Placebo (Fenofibrate)
Placebo (Fenofibrate) 145 mg daily for 12 weeks
Active Comparator: Fenofibrate + Placebo
Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
Drug: Placebo (Rosiglitazone)
Placebo (Rosiglitazone) 8mg daily for 12 weeks
Drug: Fenofibrate
Fenofibrate 145 mg daily for 12 weeks
Other Name: Tricor, Triglide, Fenoglide, Lipofen and Lofibra
Experimental: Rosiglitazone +Fenofibrate
Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
Drug: Rosiglitazone
Rosiglitazone 8mg daily for 12 weeks
Other Name: Avandia
Drug: Fenofibrate
Fenofibrate 145 mg daily for 12 weeks
Other Name: Tricor, Triglide, Fenoglide, Lipofen and Lofibra
Placebo Comparator: Placebo Therapy Daily
Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
Drug: Placebo (Rosiglitazone)
Placebo (Rosiglitazone) 8mg daily for 12 weeks
Drug: Placebo (Fenofibrate)
Placebo (Fenofibrate) 145 mg daily for 12 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Fasting plasma glucose <100 mg/dl
  2. Fasting LDL <160 mg/dl and Triglyceride <400 mg/dl.

Exclusion criteria:

  1. Congestive heart failure
  2. Evidence of renal impairment (serum creatinine> 1.4mg/dL)
  3. Liver disease (ALT and/or AST above the upper level of normal)
  4. Known diabetes mellitus or impaired fasting glucose (fasting glucose ≥ 100mg/dL)
  5. LDL of ≥160mg/dL and/or triglycerides of ≥400mg/dL
  6. Pregnant or breast feeding women
  7. Prior history of an acute coronary syndrome, myocardial infarction or revascularization procedures in the past
  8. Life-threatening disease with a survival prognosis <3 years
  9. Inability to take rosiglitazone and/or fenofibrate
  10. Already on statin therapy or have been on statin therapy in the last 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819910

Locations
United States, Texas
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
Sponsors and Collaborators
Ahmad Slim
GlaxoSmithKline
Investigators
Principal Investigator: Ahmad m slim, MD Brooke Army Medical Center
Study Chair: Laudino Castillo-rojas, MD Brooke Army Medical Center
Study Director: Jennifer N Slim, DO Brooke Army Medical Center
  More Information

Publications:
1. American Diabetes association. Standards of medical care for patients with Diabetes Mellitus. Diabetes Care 1997 ;20 : Suppl 1 :55-513.
5. Troglitazone study group. The metabolic effects of troglitazone in non-insulin dependent diabetes. Diabetes 197; 46:Suppl 1:149A.
11. Weinber, R.B. Lipoprotein metabolism: hormone regulation. Hosp. Prac 1987 :June' 15 :125-145.
Dunn, F.L. Hyperlipidemia and diabetes. Med. Clin. N. Amer. 1982 ; 66 :1347-1369.
Saltiel, A.R., Olefsky, J.M. Thiazolidinedione is a high affinity ligand of peroxisome proliferator-activated receptor. J. Biol. Chem. 1996 ;270 :12953-12956.

Responsible Party: Ahmad Slim, Director, Cardiovascular Research, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT00819910     History of Changes
Other Study ID Numbers: C.2007.122
Study First Received: January 8, 2009
Results First Received: February 6, 2013
Last Updated: April 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
Type 4 hyperlipidemia
Rosiglitazone
Fenofibrate

Additional relevant MeSH terms:
Hyperlipidemias
Hypertriglyceridemia
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Rosiglitazone
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014