Trial Outcomes & Findings for Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance (NCT NCT00122447)

Results Overview

Surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

12 months of intervention

Results posted on

2013-12-05

Participant Flow

266 subjects with IGT were contacted: 121 refused, 63 ineligible, 84 screened/enrolled. Among the 84 enrolled subjects: 1 was withdrawn, 13 dropped out before randomization, 70 were randomized (17 alpha lipoic acid, 18 aspirin, 18 olmesartan, 17 placebo). After randomization, 10 dropped out, and 3 were withdrawn.

Participant milestones

Participant milestones
Measure	Aspirin (ASA) 325 mg PO Once Daily Anti-inflammatory agent	Olmesartan (ARB) 40 mg PO Once Daily Angiotensin receptor blocker (ARB)	Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily Antioxidant	Placebo Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
Overall Study STARTED	18	18	17	17
Overall Study COMPLETED	17	13	16	14
Overall Study NOT COMPLETED	1	5	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin (ASA) 325 mg PO Once Daily n=18 Participants Anti-inflammatory agent	Olmesartan (ARB) 40 mg PO Once Daily n=18 Participants Angiotensin receptor blocker (ARB)	Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily n=17 Participants Antioxidant	Placebo n=17 Participants Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day	Total n=70 Participants Total of all reporting groups
Age Continuous	51.4 years STANDARD_DEVIATION 12.8 • n=5 Participants	55.2 years STANDARD_DEVIATION 8.5 • n=7 Participants	52.4 years STANDARD_DEVIATION 7.0 • n=5 Participants	51.3 years STANDARD_DEVIATION 11.7 • n=4 Participants	52.6 years STANDARD_DEVIATION 10.2 • n=21 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	6 Participants n=4 Participants	39 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	11 Participants n=4 Participants	31 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	13 participants n=5 Participants	12 participants n=7 Participants	10 participants n=5 Participants	14 participants n=4 Participants	49 participants n=21 Participants
Race/Ethnicity, Customized White	5 participants n=5 Participants	6 participants n=7 Participants	7 participants n=5 Participants	3 participants n=4 Participants	21 participants n=21 Participants

PRIMARY outcome

Timeframe: 12 months of intervention

Population: Based on the number of subjects who completed 12 months of intervention and testing

Surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression

Outcome measures

Outcome measures
Measure	Aspirin (ASA) 325 mg PO Once Daily n=17 Participants Anti-inflammatory agent	Olmesartan (ARB) 40 mg PO Once Daily n=13 Participants Angiotensin receptor blocker (ARB)	Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily n=15 Participants Antioxidant	Placebo n=13 Participants Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
AIM 1: Change in Flow Mediated Dilation (FMD) (%)	-0.0012 percentage of arterial dilation change Standard Deviation 0.030	0.018 percentage of arterial dilation change Standard Deviation 0.032	0.014 percentage of arterial dilation change Standard Deviation 0.034	0.0053 percentage of arterial dilation change Standard Deviation 0.030

SECONDARY outcome

Timeframe: 12 months of intervention

Population: Based on the number of subjects who completed 12 months of intervention and testing

Inflammatory marker

Outcome measures

Outcome measures
Measure	Aspirin (ASA) 325 mg PO Once Daily n=11 Participants Anti-inflammatory agent	Olmesartan (ARB) 40 mg PO Once Daily n=11 Participants Angiotensin receptor blocker (ARB)	Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily n=11 Participants Antioxidant	Placebo n=10 Participants Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level	-1.27 mg/L Standard Error 0.86	-2.34 mg/L Standard Error 1.1	0.23 mg/L Standard Error 0.70	0.32 mg/L Standard Error 0.56

OTHER_PRE_SPECIFIED outcome

Timeframe: Cross-sectional

Comparison of FMD (measure of endothelial function) between NGT, IGT and diabetes at baseline. FMD is a surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression. No analysis was conducted due to under-recruitment.

Outcome measures

Outcome data not reported

Adverse Events

Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Olmesartan

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Alpha Lipoic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enrolled, But Not Yet Randomized

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aspirin n=18 participants at risk Anti-inflammatory agent	Olmesartan n=18 participants at risk Angiotensin receptor blocker (ARB)	Alpha Lipoic Acid n=17 participants at risk Antioxidant	Placebo n=17 participants at risk Aspirin placebo once a day Olmesartan placebo once a day Alpha lipoic acid placebo twice a day	Enrolled, But Not Yet Randomized n=14 participants at risk Enrolled into study, but not yet randomized to study medication
Gastrointestinal disorders Cancer	0.00% 0/18 • 12 months	0.00% 0/18 • 12 months	0.00% 0/17 • 12 months	0.00% 0/17 • 12 months	7.1% 1/14 • Number of events 1 • 12 months

Other adverse events

Other adverse events
Measure	Aspirin n=18 participants at risk Anti-inflammatory agent	Olmesartan n=18 participants at risk Angiotensin receptor blocker (ARB)	Alpha Lipoic Acid n=17 participants at risk Antioxidant	Placebo n=17 participants at risk Aspirin placebo once a day Olmesartan placebo once a day Alpha lipoic acid placebo twice a day	Enrolled, But Not Yet Randomized n=14 participants at risk Enrolled into study, but not yet randomized to study medication
Cardiac disorders Reaction to nitroglycerin during FMD test	0.00% 0/18 • 12 months	5.6% 1/18 • Number of events 1 • 12 months	0.00% 0/17 • 12 months	0.00% 0/17 • 12 months	0.00% 0/14 • 12 months

Additional Information

Mary Rhee, M.D.

Emory University School of Medicine

Phone: 404-778-1660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place