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

Primary Purpose

Metabolic Syndrome

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Low Intensity Exercise + Metformin

High Intensity Exercise + Metformin

Low Intensity Exercise + Placebo

High Intensity Exercise + Placebo

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

LoEx+placebo

HiEx+placebo

LoEx+metformin

HiEx+metformin

Arm Description

Subjects will participate in 3 supervised training sessions and 2 unsupervised training sessions and receive placebo.

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.

If subjects are assigned to this group you will participate in the same HiEx exercise program and receive metformin as outlined above.

Outcomes

Primary Outcome Measures

Change in Flow Mediated Dilation of brachial artery

Measure of blood flow

Secondary Outcome Measures

Change in Metabolic Insulin Sensitivity by the Euglycemic Clamp

Measure of glucose metabolism

Change in Post Ischemic Flow Velocity in brachial artery

Measure of blood flow

Change in Contrast Enhanced Ultrasound

Measure of Microvascular blood flow

Change in Pulse Wave Velocity

Measure of Arterial Stiffness

Change in Augmentation Index

Measure of Arterial Stiffness

Change in Ambulatory Blood Pressure

Measure of Vascular health

Full Information

NCT ID

NCT03355469

First Posted

November 7, 2017

Last Updated

April 10, 2023

Sponsor

Rutgers University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT03355469

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 7, 2017 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LoEx+placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will participate in 3 supervised training sessions and 2 unsupervised training sessions and receive placebo.

Arm Title

HiEx+placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will participate in 3 supervised training sessions and 2 unsupervised training sessions and receive placebo.

Arm Title

LoEx+metformin

Arm Type

Active Comparator

Arm Description

Arm Title

HiEx+metformin

Arm Type

Active Comparator

Arm Description

If subjects are assigned to this group you will participate in the same HiEx exercise program and receive metformin as outlined above.

Intervention Type

Drug

Intervention Name(s)

Low Intensity Exercise + Metformin

Intervention Description

Low Intensity exercise (LoEx) measured by a percentage of maximal heart rate in combination with metformin.

Intervention Type

Drug

Intervention Name(s)

High Intensity Exercise + Metformin

Intervention Description

High Intensity exercise (HiEx) measured by a percentage of maximal heart rate in combination with metformin.

Intervention Type

Drug

Intervention Name(s)

Low Intensity Exercise + Placebo

Intervention Description

Low Intensity exercise (LoEx) measured by a percentage of maximal heart rate in combination with placebo.

Intervention Type

Drug

Intervention Name(s)

High Intensity Exercise + Placebo

Intervention Description

High Intensity exercise (HiEx) measured by a percentage of maximal heart rate in combination with placebo.

Primary Outcome Measure Information:

Title

Change in Flow Mediated Dilation of brachial artery

Description

Measure of blood flow

Time Frame

At 0 and 16 weeks

Secondary Outcome Measure Information:

Title

Change in Metabolic Insulin Sensitivity by the Euglycemic Clamp

Description

Measure of glucose metabolism

Time Frame

At 0 and 16 weeks

Title

Change in Post Ischemic Flow Velocity in brachial artery

Description

Measure of blood flow

Time Frame

At 0 and 16 weeks

Title

Change in Contrast Enhanced Ultrasound

Description

Measure of Microvascular blood flow

Time Frame

At 0 and 16 weeks

Title

Change in Pulse Wave Velocity

Description

Measure of Arterial Stiffness

Time Frame

At 0 and 16 weeks

Title

Change in Augmentation Index

Description

Measure of Arterial Stiffness

Time Frame

At 0 and 16 weeks

Title

Change in Ambulatory Blood Pressure

Description

Measure of Vascular health

Time Frame

At 0 and 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Applied Metabolism and Physiology Lab

Phone

434-243-8677

slm4ps@virginia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven K Malin, PhD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22904

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephanie Miller, M.S.Ed.

Phone

434-243-8677

slm4ps@virginia.edu

First Name & Middle Initial & Last Name & Degree

Emily Heiston, M.S.Ed

First Name & Middle Initial & Last Name & Degree

Monique Francois, PhD

First Name & Middle Initial & Last Name & Degree

Steven K Malin, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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