Trial Outcomes & Findings for Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides. (NCT NCT00186537)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2017-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	Fenofibrate 160 mg daily for 12 weeks Fenofibrate	Rosiglitazone 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss
Overall Study STARTED	19	12	16
Overall Study COMPLETED	12	12	13
Overall Study NOT COMPLETED	7	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Fenofibrate 160 mg daily for 12 weeks Fenofibrate	Rosiglitazone 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss
Overall Study Withdrawal by Subject	4	0	3
Overall Study ALT > 1.5 x ULN	3	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fenofibrate n=12 Participants 160 mg daily for 12 weeks Fenofibrate	Rosiglitazone n=12 Participants 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet n=13 Participants calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss	Total n=37 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 7 • n=99 Participants	52 years STANDARD_DEVIATION 6 • n=107 Participants	53 years STANDARD_DEVIATION 7 • n=206 Participants	53 years STANDARD_DEVIATION 7 • n=7 Participants
Gender Female	3 Participants n=99 Participants	5 Participants n=107 Participants	6 Participants n=206 Participants	14 Participants n=7 Participants
Gender Male	9 Participants n=99 Participants	7 Participants n=107 Participants	7 Participants n=206 Participants	23 Participants n=7 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: Triglycerides

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

Outcome measures

Outcome measures
Measure	Fenofibrate n=12 Participants 160 mg daily for 12 weeks Fenofibrate	Rosiglitazone n=12 Participants 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet n=13 Participants calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss
Pre- and Post-Intervention Triglyceride Levels pre treatment	231 mg/dL Standard Deviation 117	209 mg/dL Standard Deviation 67	201 mg/dL Standard Deviation 121
Pre- and Post-Intervention Triglyceride Levels post treatment	140 mg/dL Standard Deviation 47	232 mg/dL Standard Deviation 72	143 mg/dL Standard Deviation 49

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: LDL cholesterol

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

Outcome measures

Outcome measures
Measure	Fenofibrate n=12 Participants 160 mg daily for 12 weeks Fenofibrate	Rosiglitazone n=12 Participants 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet n=13 Participants calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss
Pre- and Post-Intervention LDL Cholesterol Levels pre treatment	114 mg/dL Standard Deviation 34	119 mg/dL Standard Deviation 41	144 mg/dL Standard Deviation 34
Pre- and Post-Intervention LDL Cholesterol Levels post treatment	111 mg/dL Standard Deviation 22	129 mg/dL Standard Deviation 37	128 mg/dL Standard Deviation 34

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: HDL Cholesterol

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

Outcome measures

Outcome measures
Measure	Fenofibrate n=12 Participants 160 mg daily for 12 weeks Fenofibrate	Rosiglitazone n=12 Participants 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet n=13 Participants calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss
Pre- and Post-Intervention HDL Cholesterol Levels pre treatment	35 mg/dL Standard Deviation 7	40 mg/dL Standard Deviation 11	38 mg/dL Standard Deviation 9
Pre- and Post-Intervention HDL Cholesterol Levels Post treatment	36 mg/dL Standard Deviation 8	42 mg/dL Standard Deviation 13	38 mg/dL Standard Deviation 7

Adverse Events

Fenofibrate

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Rosiglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Calorie Restricted Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fenofibrate n=19 participants at risk 160 mg daily for 12 weeks Fenofibrate	Rosiglitazone n=12 participants at risk 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks Rosiglitazone	Calorie Restricted Diet n=16 participants at risk calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks Weight Loss
Hepatobiliary disorders alanine aminotramsferase ( ALT) elevation greater than 1.5 times normal of upper limit	15.8% 3/19 • Number of events 3	0.00% 0/12	0.00% 0/16

Additional Information

Dr. Gerald Reaven

Stanford University

Phone: 650-724-3416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place