Exercise Dose and Metformin for Vascular Health in Adults With Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT03355469 |
Recruitment Status :
Active, not recruiting
First Posted : November 28, 2017
Last Update Posted : January 29, 2021
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Condition or disease | Intervention/treatment | Phase |
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Metabolic Syndrome | Drug: Low Intensity Exercise + Metformin Drug: High Intensity Exercise + Metformin Drug: Low Intensity Exercise + Placebo Drug: High Intensity Exercise + Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Each subject will be randomly assigned to receive low intensity exercise training + placebo, high intensity exercise training + placebo, or these exercise programs with metformin. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Exercise Dose and Metformin for Vascular Health in Adults With Metabolic Syndrome |
Actual Study Start Date : | August 7, 2017 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | January 31, 2022 |

Arm | Intervention/treatment |
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Placebo Comparator: LoEx+placebo
Subjects will participate in 3 supervised training sessions and 2 unsupervised training sessions and receive placebo.
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Drug: Low Intensity Exercise + Placebo
Low Intensity exercise (LoEx) measured by a percentage of maximal heart rate in combination with placebo. |
Placebo Comparator: HiEx+placebo
Subjects will participate in 3 supervised training sessions and 2 unsupervised training sessions and receive placebo.
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Drug: High Intensity Exercise + Placebo
High Intensity exercise (HiEx) measured by a percentage of maximal heart rate in combination with placebo. |
Active Comparator: LoEx+metformin
If subjects are assigned to this group they will participate in the same LoEx exercise program as outlined above. But, here they will be provided metformin. Metformin is a common medication routinely used to treat high blood sugar and has secondary effects on vascular health. Subjects will not be able to find out if you are on metformin until the study is done. If their doctor needs to know, the people doing this study can find out.
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Drug: Low Intensity Exercise + Metformin
Low Intensity exercise (LoEx) measured by a percentage of maximal heart rate in combination with metformin. |
Active Comparator: HiEx+metformin
If subjects are assigned to this group you will participate in the same HiEx exercise program and receive metformin as outlined above.
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Drug: High Intensity Exercise + Metformin
High Intensity exercise (HiEx) measured by a percentage of maximal heart rate in combination with metformin. |
- Change in Flow Mediated Dilation of brachial artery [ Time Frame: At 0 and 16 weeks ]Measure of blood flow
- Change in Metabolic Insulin Sensitivity by the Euglycemic Clamp [ Time Frame: At 0 and 16 weeks ]Measure of glucose metabolism
- Change in Post Ischemic Flow Velocity in brachial artery [ Time Frame: At 0 and 16 weeks ]Measure of blood flow
- Change in Contrast Enhanced Ultrasound [ Time Frame: At 0 and 16 weeks ]Measure of Microvascular blood flow
- Change in Pulse Wave Velocity [ Time Frame: At 0 and 16 weeks ]Measure of Arterial Stiffness
- Change in Augmentation Index [ Time Frame: At 0 and 16 weeks ]Measure of Arterial Stiffness
- Change in Ambulatory Blood Pressure [ Time Frame: At 0 and 16 weeks ]Measure of Vascular health

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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female >40 and <70 years old.
- Has a body mass index >27 and <47 kg/m2.
- Not diagnosed with Type 2 diabetes.
- Not currently engaged in > 60 min/wk of exercise
- Meet at least 3 of 5 National Cholesterol Education Adult Treatment Panel III
Metabolic Syndrome criteria:
- Increased waist circumference (≥102 cm in men; ≥88 cm in women)
- Elevated triglycerides (≥150 mg/dl), or on medication for treating the condition
- Reduced HDL-cholesterol (<40mg/dl in men, <50 mg/dl in women), or on medication for treating the condition
- High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic), or on medication for treating the condition
- Elevated fasting glucose (≥100 mg/dl), or on medication for treating the condition
Exclusion Criteria:
- Morbidly obese patients (BMI >47 kg/m2) and overweight/lean patients (BMI <27 kg/m2)
- Evidence of type 1 diabetes and diabetics requiring insulin therapy.
- Subjects who have not been weight stable (>2 kg weight change in past 3 months)
- Subjects who have been recently active (>30 min of moderate/high intensity exercise, 2 times/week).
- Subjects who are smokers or who have quit smoking <5 years ago
- Subjects prescribed metformin or have taken metformin within 1 year.
- Subjects with abnormal estimated glomerular filtration rate (eGFR).
- Hypertriglyceridemic (>400 mg/dl) and hypercholesterolemic (>260 mg/dl) subjects
- Hypertensive (>160/100 mmHg)
- Subjects currently taking medications that affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers).
- Subjects with a history of significant metabolic, cardiac, congestive heart failure, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures, or impact subject safety.
- Pregnant (as evidenced by positive pregnancy test) or nursing women
- Subjects with contraindications to participation in an exercise training program
- Currently taking active weight suppression medication (e.g. phentermine,orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzephetamine, diethylpropion, phendimetrazine)
- Known hypersensitivity to perflutren (contained in Definity)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355469
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22904 |
Principal Investigator: | Steven K Malin, PhD | University of Virginia |
Responsible Party: | Steven K Mallin, PhD, Principal Investigator, Rutgers University |
ClinicalTrials.gov Identifier: | NCT03355469 |
Other Study ID Numbers: |
19364 1R01HL130296-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | November 28, 2017 Key Record Dates |
Last Update Posted: | January 29, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Metabolic Syndrome Syndrome Disease Pathologic Processes Insulin Resistance Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Metformin Hypoglycemic Agents Physiological Effects of Drugs |