Trial · NCT00246376

Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia

NCT00246376, Not applicable, Completed, Baylor College of Medicine; results first posted 2016-03-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia. Trials, record NCT00246376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00246376

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia
NCT number: NCT00246376
Status: Completed
Phases: Not applicable
Enrollment: 221 participants, actual
Lead sponsor: Baylor College of Medicine
Conditions: Cardiovascular Diseases, Heart Diseases, HIV Infections, Hyperlipidemia, Hypertriglyceridemia, Insulin Resistance, Atherosclerosis
Interventions: Diet, Exercise, Niacin, Fenofibrate, Placebos
First posted: 2005-10-31
Last updated: 2016-03-21
Results first posted: 2016-03-21
Limitations and caveats: High dropout rate, especially by loss to follow-up (with no explanation). Flushing was common among patients taking niacin, and this (with transportation and socio-economc problems) could have contributed to the high drop-out rate.

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Triglycerides	Measured at 24 weeks	Triglycerides (mg/dL): Fasting lipid levels
Primary	Non-HDL-C	Measured at 24 weeks	non-HDL-C (mg/dL): Fasting lipid levels
Primary	HDL-C	Measured at 24 weeks	HDL-C (mg/dL): Fasting lipid levels
Primary	Total Cholesterol	Measured at 24 weeks	Total cholesterol (mg/dL): Fasting lipid levels
Primary	Total Cholesterol : HDL-C Ratio	Measured at 24 weeks	Total cholesterol : HDL-C ratio: Fasting lipid levels
Secondary	Insulin Sensitivity	Measured at 24 weeks	Adiponectin (micrograms/ml)
Secondary	Body Composition	Measured at 24 weeks	1. Body cell mass (kg) 2. Fat mass (kg)

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Triglycerides	Measured at 24 weeks	All those who underwent the 2-week (first follow-up) measurement and continued in the study.	mg/dL	MEAN
SECONDARY	Insulin Sensitivity	Measured at 24 weeks	All subjects who completed 24 weeks.	micrograms/ml	MEAN
SECONDARY	Body Composition	Measured at 24 weeks	The number corresponds to the number of subjects who completed the study (see Participant flow)	kg	MEAN
PRIMARY	Non-HDL-C	Measured at 24 weeks	All those who underwent the 2-week (first follow-up) measurement and continued in the study.	mg/dl	MEAN
PRIMARY	HDL-C	Measured at 24 weeks	All those who underwent the 2-week (first follow-up) measurement and continued in the study.	mg/dl	MEAN
PRIMARY	Total Cholesterol	Measured at 24 weeks	All those who underwent the 2-week (first follow-up) measurement and continued in the study.	mg/dL	MEAN
PRIMARY	Total Cholesterol : HDL-C Ratio	Measured at 24 weeks	All those who underwent the 2-week (first follow-up) measurement and continued in the study.	ratio	MEAN

Source ClinicalTrials.gov

Results by group55

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Triglycerides	Group 1 - Usual Care		199	Standard Error 24.9	mg/dL
Triglycerides	Group 2 - Diet/Exercise Only		216.9	Standard Error 28.6	mg/dL
Triglycerides	Group 3 - Diet/Exercise + Fenofibrate		155.1	Standard Error 18.5	mg/dL
Triglycerides	Group 4 - Diet/Exercise + Niacin		177.6	Standard Error 24.2	mg/dL
Triglycerides	Group 5 - Diet/Exercise + Fenofibrate + Niacin		135.6	Standard Error 16.9	mg/dL
Insulin Sensitivity	Group 1 - Usual Care	Fasting insulin	8.7	Standard Error 2	micrograms/ml
Insulin Sensitivity	Group 2 - Diet/Exercise Only	Fasting insulin	6.7	Standard Error 1.6	micrograms/ml
Insulin Sensitivity	Group 3 - Diet/Exercise + Fenofibrate	Fasting insulin	9.5	Standard Error 1.6	micrograms/ml
Insulin Sensitivity	Group 4 - Diet/Exercise + Niacin	Fasting insulin	11.9	Standard Error 3	micrograms/ml
Insulin Sensitivity	Group 5 - Diet/Exercise + Fenofibrate + Niacin	Fasting insulin	10.3	Standard Error 2.5	micrograms/ml

1 to 10 of 55Source ClinicalTrials.gov

See all 55 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group 1: Usual Care	41
Overall Study	STARTED	Group 2: Diet / Exercise	43
Overall Study	STARTED	Group 3: Diet / Exercise + Fenofibrate	45
Overall Study	STARTED	Group 4: Diet / Exercise + Niacin	47
Overall Study	STARTED	Group 5: Diet / Exercise + Niacin + Fenofibrate	45
Overall Study	After Dietary run-in at Two Weeks	Group 1: Usual Care	30
Overall Study	After Dietary run-in at Two Weeks	Group 2: Diet / Exercise	38
Overall Study	After Dietary run-in at Two Weeks	Group 3: Diet / Exercise + Fenofibrate	41
Overall Study	After Dietary run-in at Two Weeks	Group 4: Diet / Exercise + Niacin	40
Overall Study	After Dietary run-in at Two Weeks	Group 5: Diet / Exercise + Niacin + Fenofibrate	42

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events115

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	Group 1: Usual Care	3	30	3
other	Diarrhea	Gastrointestinal disorders	Group 2: Diet / Exercise	1	38	1
other	Diarrhea	Gastrointestinal disorders	Group 3: Diet / Exercise + Fenofibrate	2	41	2
other	Diarrhea	Gastrointestinal disorders	Group 4: Diet / Exercise + Niacin	2	40	2
other	Diarrhea	Gastrointestinal disorders	Group 5: Diet / Exercise + Niacin + Fenofibrate	0	42	0
other	Nausea/Vomiting	Gastrointestinal disorders	Group 1: Usual Care	2	30	2
other	Nausea/Vomiting	Gastrointestinal disorders	Group 2: Diet / Exercise	1	38	1
other	Nausea/Vomiting	Gastrointestinal disorders	Group 3: Diet / Exercise + Fenofibrate	4	41	4
other	Nausea/Vomiting	Gastrointestinal disorders	Group 4: Diet / Exercise + Niacin	0	40	0
other	Nausea/Vomiting	Gastrointestinal disorders	Group 5: Diet / Exercise + Niacin + Fenofibrate	3	42	3

1 to 10 of 115Source ClinicalTrials.gov

See all 115 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group 1: Usual Care
Total, all-cause mortality	Group 2: Diet / Exercise
Total, all-cause mortality	Group 3: Diet / Exercise + Fenofibrate
Total, all-cause mortality	Group 4: Diet / Exercise + Niacin
Total, all-cause mortality	Group 5: Diet / Exercise + Niacin + Fenofibrate
Total, other adverse events	Group 1: Usual Care	17	30
Total, other adverse events	Group 2: Diet / Exercise	11	38
Total, other adverse events	Group 3: Diet / Exercise + Fenofibrate	12	41
Total, other adverse events	Group 4: Diet / Exercise + Niacin	33	40
Total, other adverse events	Group 5: Diet / Exercise + Niacin + Fenofibrate	25	42

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
16914390	BACKGROUND	PubMed
21565796	RESULT	PubMed
23299761	DERIVED	PubMed
23522788	DERIVED	PubMed
23640486	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL073696	Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy	BALASUBRAMANYAM, ASHOK	BAYLOR COLLEGE OF MEDICINE	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2003 to 2008

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00246376

GET https://conductscience.org/api/trials/v1/NCT00246376/results?page=2

API reference For AI assistants