Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 23 for:    "Hyperinsulinism" | "Fenofibrate"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00186537
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : May 5, 2016
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Gerald M Reaven, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Insulin Resistance
Hypertriglyceridemia
Interventions Drug: Rosiglitazone
Drug: Fenofibrate
Behavioral: Weight Loss
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fenofibrate Rosiglitazone Calorie Restricted Diet
Hide Arm/Group Description

160 mg daily for 12 weeks

Fenofibrate

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

Rosiglitazone

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

Weight Loss

Period Title: Overall Study
Started 19 12 16
Completed 12 12 13
Not Completed 7 0 3
Reason Not Completed
Withdrawal by Subject             4             0             3
ALT > 1.5 x ULN             3             0             0
Arm/Group Title Fenofibrate Rosiglitazone Calorie Restricted Diet Total
Hide Arm/Group Description

160 mg daily for 12 weeks

Fenofibrate

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

Rosiglitazone

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

Weight Loss

Total of all reporting groups
Overall Number of Baseline Participants 12 12 13 37
Hide Baseline Analysis Population Description
Baseline analysis was done on those who completed the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 13 participants 37 participants
55  (7) 52  (6) 53  (7) 53  (7)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 13 participants 37 participants
Female
3
  25.0%
5
  41.7%
6
  46.2%
14
  37.8%
Male
9
  75.0%
7
  58.3%
7
  53.8%
23
  62.2%
1.Primary Outcome
Title Pre- and Post-Intervention Triglyceride Levels
Hide Description Compare the change in mean triglyceride levels between groups after the interventions
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Triglycerides
Arm/Group Title Fenofibrate Rosiglitazone Calorie Restricted Diet
Hide Arm/Group Description:

160 mg daily for 12 weeks

Fenofibrate

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

Rosiglitazone

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

Weight Loss

Overall Number of Participants Analyzed 12 12 13
Mean (Standard Deviation)
Unit of Measure: mg/dL
pre treatment 231  (117) 209  (67) 201  (121)
post treatment 140  (47) 232  (72) 143  (49)
2.Primary Outcome
Title Pre- and Post-Intervention LDL Cholesterol Levels
Hide Description Compare the change in mean LDL Cholesterol levels between groups after the interventions
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LDL cholesterol
Arm/Group Title Fenofibrate Rosiglitazone Calorie Restricted Diet
Hide Arm/Group Description:

160 mg daily for 12 weeks

Fenofibrate

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

Rosiglitazone

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

Weight Loss

Overall Number of Participants Analyzed 12 12 13
Mean (Standard Deviation)
Unit of Measure: mg/dL
pre treatment 114  (34) 119  (41) 144  (34)
post treatment 111  (22) 129  (37) 128  (34)
3.Primary Outcome
Title Pre- and Post-Intervention HDL Cholesterol Levels
Hide Description Compare the change in mean HDL Cholesterol levels between groups after the interventions
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
HDL Cholesterol
Arm/Group Title Fenofibrate Rosiglitazone Calorie Restricted Diet
Hide Arm/Group Description:

160 mg daily for 12 weeks

Fenofibrate

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

Rosiglitazone

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

Weight Loss

Overall Number of Participants Analyzed 12 12 13
Mean (Standard Deviation)
Unit of Measure: mg/dL
pre treatment 35  (7) 40  (11) 38  (9)
Post treatment 36  (8) 42  (13) 38  (7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fenofibrate Rosiglitazone Calorie Restricted Diet
Hide Arm/Group Description

160 mg daily for 12 weeks

Fenofibrate

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

Rosiglitazone

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

Weight Loss

All-Cause Mortality
Fenofibrate Rosiglitazone Calorie Restricted Diet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fenofibrate Rosiglitazone Calorie Restricted Diet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/12 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fenofibrate Rosiglitazone Calorie Restricted Diet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/19 (15.79%)      0/12 (0.00%)      0/16 (0.00%)    
Hepatobiliary disorders       
alanine aminotramsferase ( ALT) elevation greater than 1.5 times normal of upper limit   3/19 (15.79%)  3 0/12 (0.00%)  0 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Gerald Reaven
Organization: Stanford University
Phone: 650-724-3416
Responsible Party: Gerald M Reaven, Stanford University
ClinicalTrials.gov Identifier: NCT00186537     History of Changes
Other Study ID Numbers: 79301
SPO 28829
First Submitted: September 14, 2005
First Posted: September 16, 2005
Results First Submitted: April 1, 2016
Results First Posted: May 5, 2016
Last Update Posted: January 12, 2017