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Exercise Dose and Metformin for Vascular Health in Adults With Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03355469
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steven K. Malin, PhD, University of Virginia

Study Description
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Brief Summary:
Health organizations recommend exercise in an intensity based manner to promote cardiovascular adaptation and prevent disease. Metformin is a common anti-diabetes medication that reduces future type 2 diabetes and cardiovascular disease (CVD) risk. However, the optimal dose of exercise to be combined with metformin for vascular health remains unknown. The purpose of this study is to evaluate whether combining high or low intensity exercise with metformin has the potential to outperform either exercise intensity alone on blood flow across the arterial tree as well as impact insulin action in individuals with metabolic syndrome. Identification of such outcomes will indicate 1) whether and how metformin should be combined with physical activity for CVD prevention, 2) provide the first indication of whether exercise intensity reduces CVD risk via multi-level vasculature function vs. metabolic insulin action, and 3) provide a rational early treatment for people with metabolic syndrome to prevent/treat type 2 diabetes and CVD.

Condition or disease Intervention/treatment Phase
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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: LoEx+placebo
Subjects will participate in 3 supervised training sessions and 2 unsupervised training sessions and receive placebo.
 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.
 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.
 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.
 Drug: High Intensity Exercise + Metformin
High Intensity exercise (HiEx) measured by a percentage of maximal heart rate in combination with metformin.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Flow Mediated Dilation of brachial artery [ Time Frame: At 0 and 16 weeks ]
    Measure of blood flow


Secondary Outcome Measures :
  1. Change in Metabolic Insulin Sensitivity by the Euglycemic Clamp [ Time Frame: At 0 and 16 weeks ]
    Measure of glucose metabolism

  2. Change in Post Ischemic Flow Velocity in brachial artery [ Time Frame: At 0 and 16 weeks ]
    Measure of blood flow

  3. Change in Contrast Enhanced Ultrasound [ Time Frame: At 0 and 16 weeks ]
    Measure of Microvascular blood flow

  4. Change in Pulse Wave Velocity [ Time Frame: At 0 and 16 weeks ]
    Measure of Arterial Stiffness

  5. Change in Augmentation Index [ Time Frame: At 0 and 16 weeks ]
    Measure of Arterial Stiffness

  6. Change in Ambulatory Blood Pressure [ Time Frame: At 0 and 16 weeks ]
    Measure of Vascular health


Eligibility Criteria
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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
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Applied Metabolism and Physiology Lab 434-243-8677 slm4ps@virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22904
Contact: Stephanie Miller, M.S.Ed.    434-243-8677    slm4ps@virginia.edu   
Sub-Investigator: Emily Heiston, M.S.Ed         
Sub-Investigator: Monique Francois, PhD         
Principal Investigator: Steven K Malin, PhD         
Sponsors and Collaborators
University of Virginia
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Steven K Malin, PhD University of Virginia
More Information
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Publications:

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Responsible Party: Steven K. Malin, PhD, Principal Investigator, University of Virginia
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 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs