Exercise Dose and Metformin for Vascular Health in Metabolic Syndrome

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

August 7, 2017

Primary Completion Date

March 11, 2024

Study Completion Date

May 23, 2024

Conditions
Metabolic Syndrome
Interventions
DRUG

Metformin

Oral metformin 2000 mg/d for 16 weeks. Metformin dosage will follow 500 mg/d ramp up progression: Week 1 = 500 mg/d; Week 2 = 1,000 mg/d; Week 3 = 1500 mg/d; Week 4-16 = 2000 mg/d.

DRUG

Placebo

Oral placebo for 16 weeks. Placebo tablets will follow a four-stage progression: Week 1 = 1 tablet; Week 2 = 2 tablets; Week 3 = 3 tablets; Week 4-16 = 4 tablets.

BEHAVIORAL

Low Intensity Exercise

Low intensity exercise will consist of 16 weeks of walking at \~55% of each participant's predetermined VO2max and monitored via heart rate. Supervised exercised will occur on a treadmill 3d/wk and the duration will be determined based on individual fitness levels to expand 400 kcals. Supervised exercise training will follow a three-phase progression: Weeks 1-2 = 3 supervised sessions at 75% duration; Week 3-4 = 3 supervised sessions at 87% duration; Weeks 5-16 = 3 supervised sessions at 100% duration. Unsupervised exercised will be 2d/wk and the duration will half the time of the supervised training sessions.

BEHAVIORAL

High Intensity Exercise

High intensity exercise will consist of 16 weeks of walking at \~85% of each participant's predetermined VO2max and monitored via heart rate. Supervised exercised will occur on a treadmill 3d/wk and the duration will be determined based on individual fitness levels to expand 400 kcals. Supervised exercise training will follow a three-phase progression: Weeks 1-2 = 3 supervised sessions at 75% duration; Week 3-4 = 3 supervised sessions at 87% duration; Weeks 5-16 = 3 supervised sessions at 100% duration. Unsupervised exercised will be 2d/wk and the duration will half the time of the supervised training sessions.

Trial Locations (1)

08901

Rutgers University Loree Gymnasium, New Brunswick

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Rutgers University

OTHER

NCT03355469 - Exercise Dose and Metformin for Vascular Health in Metabolic Syndrome | Biotech Hunter | Biotech Hunter