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Behavioural Intervention

Exercise + Metformin for Metabolic Syndrome

Phase 2 & 3
Recruiting
Led By Steven K Malin, PhD
Research Sponsored by Rutgers University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not diagnosed with Type 2 diabetes
Meets 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 0 and 16 weeks
Awards & highlights

Study Summary

This trial is testing whether combining high or low intensity exercise with metformin improves blood flow and insulin action more than exercise or metformin alone in people with metabolic syndrome.

Who is the study for?
Adults aged 40-70 with metabolic syndrome, BMI between 27 and 47, not exercising more than an hour a week. Must meet at least three criteria for metabolic syndrome but can't have type 2 diabetes or be on metformin. Excludes those with significant health issues, smokers or recent quitters, pregnant/nursing women, and anyone on certain heart medications.Check my eligibility
What is being tested?
The study is testing the combination of high or low intensity exercise with metformin versus exercise alone to improve blood flow and insulin action in adults with metabolic syndrome. It aims to find the best strategy for preventing cardiovascular disease and type 2 diabetes.See study design
What are the potential side effects?
Metformin may cause stomach upset, diarrhea, muscle pain, or a metallic taste in the mouth. Exercise might lead to muscle soreness or injury if not done properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have Type 2 diabetes.
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I meet at least 3 of the criteria for metabolic syndrome.
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I am between 40 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0 and 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 0 and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Flow Mediated Dilation of brachial artery
Secondary outcome measures
Change in Ambulatory Blood Pressure
Change in Augmentation Index
Change in Contrast Enhanced Ultrasound
+3 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: HiEx+metforminActive Control1 Intervention
If subjects are assigned to this group you will participate in the same HiEx exercise program and receive metformin as outlined above.
Group II: LoEx+metforminActive Control1 Intervention
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.
Group III: LoEx+placeboPlacebo Group1 Intervention
Subjects will participate in 3 supervised training sessions and 2 unsupervised training sessions and receive placebo.
Group IV: HiEx+placeboPlacebo Group1 Intervention
Subjects will participate in 3 supervised training sessions and 2 unsupervised training sessions and receive placebo.

Find a Location

Who is running the clinical trial?

Rutgers UniversityLead Sponsor
114 Previous Clinical Trials
2,804,293 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,848 Previous Clinical Trials
47,818,182 Total Patients Enrolled
34 Trials studying Metabolic Syndrome
19,470 Patients Enrolled for Metabolic Syndrome
Steven K Malin, PhDPrincipal InvestigatorUniversity of Virginia
3 Previous Clinical Trials
183 Total Patients Enrolled
2 Trials studying Metabolic Syndrome
143 Patients Enrolled for Metabolic Syndrome

Media Library

High Intensity Exercise (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03355469 — Phase 2 & 3
High Intensity Exercise (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03355469 — Phase 2 & 3
Metabolic Syndrome Research Study Groups: HiEx+metformin, LoEx+placebo, HiEx+placebo, LoEx+metformin
Metabolic Syndrome Clinical Trial 2023: High Intensity Exercise Highlights & Side Effects. Trial Name: NCT03355469 — Phase 2 & 3
~5 spots leftby Dec 2024
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