Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 23 for:    "Hyperinsulinism" | "Fenofibrate"

Effect of a Fibrate and a Statin on Endothelial Dysfunction

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: NCT00491400
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : June 26, 2007
Results First Posted : October 24, 2012
Last Update Posted : October 24, 2012
Sponsor:
Information provided by (Responsible Party):
Joseph A. Vita, Boston University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Diabetes Mellitus
Metabolic Syndrome
Interventions Drug: Fenofibrate
Drug: Atorvastatin
Enrollment 28
Recruitment Details Patients meeting the entry criteria were recruited at Boston Medical Center.
Pre-assignment Details 101 patients were consented and underwent screening. 73 were excluded because testing demonstrated that they were ineligible. 28 Entered the study 9 withdrew from the study
Arm/Group Title Fenofibrate First Atorvastatin First
Hide Arm/Group Description Participants randomized to receive fenofibrate first and atorvastatin second Participants randomized to receive atorvastatin first and fenofibrate second
Period Title: Overall Study
Started 15 13
Started First Treatment 14 [1] 13 [2]
Completed First Treatment 14 [3] 9 [4]
Started Second Treatment 12 [5] 9 [6]
Finished Second Treatment 10 [7] 9 [8]
Completed 10 9
Not Completed 5 4
Reason Not Completed
Withdrawal by Subject             5             4
[1]
1 withdrew prior to starting fenofibrate
[2]
None withdrew prior to starting atorvastatin
[3]
None withdrew during fenofibrate treatment (first treatment)
[4]
4 withdrew during atorvastatin treatment (first treatment)
[5]
2 withdrew during washout period
[6]
None withdrew during the washout period
[7]
2 withdrew during atorvastatin treatment (second treatment)
[8]
None withdrew during fenofibrate treatment (second treatment)
Arm/Group Title Fenofibrate First Atorvastatin First Total
Hide Arm/Group Description Fenofibrate First and Atorvastatin Second Atorvastatin First and Fenofibrate Second Total of all reporting groups
Overall Number of Baseline Participants 15 13 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 13 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
13
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 13 participants 28 participants
Female
10
  66.7%
9
  69.2%
19
  67.9%
Male
5
  33.3%
4
  30.8%
9
  32.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 13 participants 28 participants
15 13 28
1.Primary Outcome
Title Brachial Artery Flow-mediated Dilation
Hide Description Endothelial function was assessed as brachial artery flow-mediated dilation (FMD) using ultrasound. FMD is calculated as the difference in brachial diameter during hyperemic flow and brachial diameter at baseline divided by brachial diameter at baseline and expressed as percent dilation.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants is too few for meaningful analysis.
Arm/Group Title Fenofibrate Treatment Atorvastatin Treatment
Hide Arm/Group Description:
Effect of fenofibrate on brachial artery FMD
Effect of atorvastatin on brachial artery FMD
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Serum Lipids
Hide Description Effect of the intervention on total cholesterol, HDL, and triglycerides
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Enrollment was insufficient and there are too few subjects for meaningful analysis
Arm/Group Title Fenofibrate Atorvastatin
Hide Arm/Group Description:
Effect of fenofibrate treatment on lipid profile
Effect of atorvastatin treatment on lipid profile
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fenofibrate First Atorvastatin First
Hide Arm/Group Description Fenofibrate First and Atorvastatin Second Atorvastatin First and Fenofibrate Second
All-Cause Mortality
Fenofibrate First Atorvastatin First
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fenofibrate First Atorvastatin First
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/13 (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 First Atorvastatin First
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/13 (0.00%) 
Early termination due to inadequate enrollment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Joseph A. Vita, MD
Organization: Boston University
Phone: 617-638-8700
EMail: jvita@bu.edu
Responsible Party: Joseph A. Vita, Boston University
ClinicalTrials.gov Identifier: NCT00491400     History of Changes
Other Study ID Numbers: H-23185
First Submitted: June 22, 2007
First Posted: June 26, 2007
Results First Submitted: May 23, 2012
Results First Posted: October 24, 2012
Last Update Posted: October 24, 2012