Trial Outcomes & Findings for Lipid Biomarkers for Diabetic Heart Disease (NCT NCT01752842)

NCT ID: NCT01752842

Last Updated: 2019-03-15

Results Overview

Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2019-03-15

Participant Flow

Subjects were recruited from clinics, practices and laboratories within the Barnes-Jewish Hospital consortium, Volunteer for Health and Diabetes Research Connections recruitment programs at Washington University School of Medicine, and through local advertisements, posters, emails and flyers. Dates of recruitment were from May 2013 to October 2017.

Potential subjects were given the approved consent form to consider. If interested, they were scheduled for a screening visit in the Center for Applied Research Sciences. The consent form was signed before any testing took place. Blood and urine were collected and a cardiac stress test was performed to evaluate the subject for eligibility.

Participant milestones

Measure	Fenofibrate Participants were instructed to take one fenofibrate 160 mg capsule every day for 12 weeks Fenofibrate	Placebo for Fenofibrate Participants were instructed to take one inert sugar pill every day for 12 weeks Placebo for fenofibrate
Overall Study STARTED	34	36
Overall Study COMPLETED	31	34
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Fenofibrate Participants were instructed to take one fenofibrate 160 mg capsule every day for 12 weeks Fenofibrate	Placebo for Fenofibrate Participants were instructed to take one inert sugar pill every day for 12 weeks Placebo for fenofibrate
Overall Study Adverse Event	3	0
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Study-specific baseline characteristics were determined for subjects who completed the 12-week intervention only.

Baseline characteristics by cohort

Measure	Fenofibrate n=34 Participants One fenofibrate 160 mg capsule per day for 12 weeks Fenofibrate	Placebo for Fenofibrate n=36 Participants One inert sugar pill per day for 12 weeks Placebo for fenofibrate	Total n=70 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 8.2 • n=34 Participants	54.6 years STANDARD_DEVIATION 8.3 • n=36 Participants	54.4 years STANDARD_DEVIATION 8.2 • n=70 Participants
Sex: Female, Male Female	24 Participants n=34 Participants	24 Participants n=36 Participants	48 Participants n=70 Participants
Sex: Female, Male Male	10 Participants n=34 Participants	12 Participants n=36 Participants	22 Participants n=70 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=34 Participants	2 Participants n=36 Participants	3 Participants n=70 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=34 Participants	33 Participants n=36 Participants	64 Participants n=70 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=34 Participants	1 Participants n=36 Participants	3 Participants n=70 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=34 Participants	0 Participants n=36 Participants	0 Participants n=70 Participants
Race (NIH/OMB) Asian	0 Participants n=34 Participants	1 Participants n=36 Participants	1 Participants n=70 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=34 Participants	0 Participants n=36 Participants	0 Participants n=70 Participants
Race (NIH/OMB) Black or African American	7 Participants n=34 Participants	8 Participants n=36 Participants	15 Participants n=70 Participants
Race (NIH/OMB) White	27 Participants n=34 Participants	26 Participants n=36 Participants	53 Participants n=70 Participants
Race (NIH/OMB) More than one race	0 Participants n=34 Participants	1 Participants n=36 Participants	1 Participants n=70 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=34 Participants	0 Participants n=36 Participants	0 Participants n=70 Participants
Region of Enrollment United States	34 participants n=34 Participants	36 participants n=36 Participants	70 participants n=70 Participants
Cardiac Diastolic Function (E')	8.30 cm/s STANDARD_DEVIATION 1.70 • n=31 Participants • Study-specific baseline characteristics were determined for subjects who completed the 12-week intervention only.	7.99 cm/s STANDARD_DEVIATION 1.78 • n=34 Participants • Study-specific baseline characteristics were determined for subjects who completed the 12-week intervention only.	8.1 cm/s STANDARD_DEVIATION 1.7 • n=65 Participants • Study-specific baseline characteristics were determined for subjects who completed the 12-week intervention only.
Cardiac Systolic Function (Fractional Shortening)	39 percent STANDARD_DEVIATION 7 • n=31 Participants • Study-specific baseline characteristics were determined for subjects who completed the 12-week intervention only.	38 percent STANDARD_DEVIATION 6 • n=34 Participants • Study-specific baseline characteristics were determined for subjects who completed the 12-week intervention only.	38.2 percent STANDARD_DEVIATION 6.7 • n=65 Participants • Study-specific baseline characteristics were determined for subjects who completed the 12-week intervention only.
C24:0/C16:0 ceramides	11.2 ratio STANDARD_DEVIATION 2.4 • n=31 Participants • Study-specific baseline characteristics were determined for subjects who completed the 12-week intervention only.	12.4 ratio STANDARD_DEVIATION 3 • n=34 Participants • Study-specific baseline characteristics were determined for subjects who completed the 12-week intervention only.	11.8 ratio STANDARD_DEVIATION 2.8 • n=65 Participants • Study-specific baseline characteristics were determined for subjects who completed the 12-week intervention only.

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: All participants for whom E' (diastolic function) was measured at baseline and 12 weeks.

Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline.

Outcome measures

Measure	Fenofibrate n=31 Participants Participants were instructed to take one fenofibrate 160 mg capsule every day for 12 weeks Fenofibrate	Placebo for Fenofibrate n=34 Participants Participants were instructed to take one inert sugar pill every day for 12 weeks Placebo for fenofibrate
Change in Cardiac Diastolic Function as Measured by E' (cm/s)	-0.02 cm/s Standard Deviation 1.35	0.55 cm/s Standard Deviation 1.58

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: All participants for whom fractional shortening was measured at baseline and 12 weeks.

Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline.

Outcome measures

Measure	Fenofibrate n=31 Participants Participants were instructed to take one fenofibrate 160 mg capsule every day for 12 weeks Fenofibrate	Placebo for Fenofibrate n=34 Participants Participants were instructed to take one inert sugar pill every day for 12 weeks Placebo for fenofibrate
Change in Cardiac Systolic Function as Measured by Fractional Shortening Percent	0.025 percent Standard Deviation 0.090	0.030 percent Standard Deviation 0.083

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: All participants for whom C24:0 and C16:0 ceramides were measured at baseline and 12 weeks.

Mass spectrometry-based quantification of the ratio of C24:0 ceramide to C16:0 ceramide in plasma.

Outcome measures

Measure	Fenofibrate n=31 Participants Participants were instructed to take one fenofibrate 160 mg capsule every day for 12 weeks Fenofibrate	Placebo for Fenofibrate n=34 Participants Participants were instructed to take one inert sugar pill every day for 12 weeks Placebo for fenofibrate
Change in C24:0/C16:0 Ceramide Ratio	-1.6 ratio Standard Deviation 1.66	-0.03 ratio Standard Deviation 2.44

Adverse Events

Fenofibrate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo for Fenofibrate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fenofibrate n=34 participants at risk Participants were instructed to take one fenofibrate 160 mg capsule every day for 12 weeks Fenofibrate	Placebo for Fenofibrate n=36 participants at risk Participants were instructed to take one inert sugar pill every day for 12 weeks Placebo for fenofibrate
Skin and subcutaneous tissue disorders rash/itching	5.9% 2/34 • Number of events 2 • Adverse event data were collected during the 12 weeks of intervention. Participants self-reported side-effects weekly during intervention, and an interim study visit took place half-way through the 12 weeks so safety labs could be obtained.	0.00% 0/36 • Adverse event data were collected during the 12 weeks of intervention. Participants self-reported side-effects weekly during intervention, and an interim study visit took place half-way through the 12 weeks so safety labs could be obtained.

Additional Information

Jean E. Schaffer, MD

Washington University School of Medicine

Phone: 314-362-8717

Email: jschaff@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place