Trial · NCT00330733

Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk

NCT00330733, Phase 2, Phase 3, Completed, VA Office of Research and Development; results first posted 2014-04-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk. Trials, record NCT00330733. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00330733

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Trial

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

Title: Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk
NCT number: NCT00330733
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 71 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Atherosclerosis, Cardiovascular Disease, Inflammation, Insulin Resistance, Noninsulin-dependent Diabetes Mellitus
Interventions: Salsalate, Placebo
First posted: 2006-05-29
Last updated: 2020-01-21
Results first posted: 2014-04-22
Limitations and caveats: Since we did not measure endogenous glucose production and lipolysis, the effects on hepatic glucose and lipid metabolism deserve further study. Sufficient numbers of women were not included, with which to confidently extend these results to women

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Change in Systemic Glucose Disposal- Glucose Infusion Rates	3 months	Participants were admitted to the Clinical Research Units at 06:00-08:00 hours after an overnight fast. Euglycaemic-hyperinsulinaemic clamps were conducted at baseline and at the end of the study. Because salsalate therapy appears to decrease insulin clearance leading to higher circulating insulin levels during the clamp, we reduced the infusion rate of insulin in the active treatment arm by 20% (from 100 to 80 mUm-2 min-1) at the study end. Insulin solutions were prepared by the site pharmacist so that study staff remained blinded to drug assignment. Whole-body insulin sensitivity was estimated from glucose infusion rate (GIR) during last 30 min of insulin infusions.
Secondary	Glucose Area Under the Curve in These Subjects	3 months
Secondary	Plasma CRP	8 and 12 weeks	Plasma C-reactive protein was measured by PVAHS clinical laboratory. Data are reported as change from baseline at 8 and 12 weeks.
Secondary	Endothelial Function	Baseline and 12 weeks	Endothelial-mediated arterial responses using peripheral arterial tonometry (PAT; Itamar Medical, Caesarea, Israel).
Secondary	Plasma Interleukin 6	8 and 12 weeks	Plasma IL-6 was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.
Secondary	Plasma sVCAM	8 and 12 weeks	Plasma soluble VCAM was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.
Secondary	Plasma Adiponectin	8 and 12 weeks	Plasma soluble Adiponectin was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.

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	Change in Systemic Glucose Disposal- Glucose Infusion Rates	3 months	analysis was performed on all participants with available baseline and final clamp studies	percent change from baseline	MEDIAN
SECONDARY	Glucose Area Under the Curve in These Subjects	3 months	analysis was performed on all participants with available baseline and final clamp studies	mmol/l/hr	MEAN
SECONDARY	Plasma CRP	8 and 12 weeks	Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication	mg/l	MEDIAN
SECONDARY	Endothelial Function	Baseline and 12 weeks	Analysis was performed on all participants with available baseline and final clamp studies	index	MEAN
SECONDARY	Plasma Interleukin 6	8 and 12 weeks	Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication	pg/ml	MEDIAN
SECONDARY	Plasma sVCAM	8 and 12 weeks	Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication	ng/ml	MEDIAN
SECONDARY	Plasma Adiponectin	8 and 12 weeks	Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication	μg/ml	MEDIAN

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Category	Value	Spread	Units
Change in Systemic Glucose Disposal- Glucose Infusion Rates	Placebo		1	95% Confidence Interval -39 to 56	percent change from baseline
Change in Systemic Glucose Disposal- Glucose Infusion Rates	Salsalate Therapy		6	95% Confidence Interval -20 to 61	percent change from baseline
Glucose Area Under the Curve in These Subjects	Placebo		8.98	Standard Deviation 1.19	mmol/l/hr
Glucose Area Under the Curve in These Subjects	Salsalate Therapy		8.74	Standard Deviation 1.33	mmol/l/hr
Plasma CRP	Placebo	Change in CRP at 8 weeks	0	95% Confidence Interval -2.3 to 4.1	mg/l
Plasma CRP	Salsalate Therapy	Change in CRP at 8 weeks	-0.8	95% Confidence Interval -8 to 4.5	mg/l
Plasma CRP	Placebo	Change in CRP at 12 weeks	-0.1	95% Confidence Interval -2.6 to 3.6	mg/l
Plasma CRP	Salsalate Therapy	Change in CRP at 12 weeks	-.3	95% Confidence Interval -5.6 to 4.5	mg/l
Endothelial Function	Placebo	Pat Index baseline	1.8	Standard Error .5	index
Endothelial Function	Salsalate Therapy	Pat Index baseline	1.9	Standard Error .5	index

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	37
Overall Study	STARTED	Salsalate	34
Overall Study	Received Study Medication	Placebo	36
Overall Study	Received Study Medication	Salsalate	34
Overall Study	COMPLETED	Placebo	30
Overall Study	COMPLETED	Salsalate	29
Overall Study	NOT COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	Salsalate	5

Source ClinicalTrials.gov

Adverse events4

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	tinnitus	Ear and labyrinth disorders	Placebo	2	36	2
other	tinnitus	Ear and labyrinth disorders	Salsalate Therapy	4	34	4
other	nausea	Gastrointestinal disorders	Placebo	5	36	5
other	nausea	Gastrointestinal disorders	Salsalate Therapy	8	34	8

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Salsalate Therapy
Total, other adverse events	Placebo	7	36
Total, other adverse events	Salsalate Therapy	12	34
Total, serious adverse events	Placebo	0	36
Total, serious adverse events	Salsalate Therapy	0	34

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23370525	RESULT

Source PubMed

Grants0

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.

None in this release.

Trial comparisons1

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

Comparison
Salsalate Therapy vs Placebo: serious adverse events

Source Trial comparisons

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.

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