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Metformin + Exercise for Metabolic Syndrome

Phase 2 & 3

Recruiting

Led By Steven K Malin, PhD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not diagnosed with Type 2 diabetes

Age ( > 45 years old for men; > 55 years old for women)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 0 and 16 weeks

Awards & highlights

Study Summary

This trial is testing whether metformin, a common anti-diabetes medication, has any effect on the vascular function of obese people with Metabolic syndrome (MetS) when combined with exercise. The study will last 16 weeks and participants will be randomly assigned to one of four groups: 1) low-intensity exercise + placebo; 2) low-intensity exercise + metformin; 3) high-intensity exercise + placebo; or 4) high-intensity exercise + metformin.

Who is the study for?

Adults aged 40-80 with Metabolic Syndrome, not currently on metformin or engaging in significant exercise, who have a BMI between 25 and 47. Participants should have risk factors like high blood pressure, large waist circumference, or a family history of diabetes but cannot be diabetic themselves. Excludes those with serious health conditions, non-English speakers, recent smokers, pregnant/nursing women, and anyone on certain heart medications.Check my eligibility

What is being tested?

The trial is testing the combination of low (LoEx) or high intensity (HiEx) exercise with either metformin or placebo to see which improves vascular health in obese adults with Metabolic Syndrome. It's a double-blind study where participants are randomly assigned to one of four groups for 16 weeks.See study design

What are the potential side effects?

Possible side effects include gastrointestinal issues from metformin such as nausea and diarrhea; exercise may cause muscle soreness or injury if not done properly. The specific side effects will depend on the individual's reaction to both interventions.

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 am a man over 45 or a woman over 55.

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A close family member had heart disease before age 55 (if male) or 65 (if female).

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I am currently on medication that affects my heart rate or rhythm.

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My fasting blood sugar is high or I am on medication for it.

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I have been diagnosed with Polycystic Ovarian Syndrome.

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My BMI is between 25 and 47.

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I have high blood pressure or am on medication for it.

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I am between 40 and 80 years old.

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My HDL cholesterol is low or I am on medication for it.

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My waist is larger than 102 cm if I'm a man, or 88 cm if I'm a woman.

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My triglyceride levels are high or I am on medication for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 0 and 16 weeks

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: LoEx+MetforminActive Control2 Interventions

Subjects randomly assigned to this group will participate in the same 3 supervised training sessions and 2 unsupervised training sessions, but 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 find out whether or not they are on Metformin until after the study is complete. 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 placebo.

Group II: HiEx+MetforminActive Control2 Interventions

Subjects randomly assigned to this group will participate in the same HiEx 3 supervised training sessions and 2 unsupervised training sessions, but they will be provided Metformin. Drug: High Intensity Exercise + Metformin High Intensity Exercise (HiEx) measured by a percentage of maximal heart rate in combination with placebo.

Group III: LoEx+PlaceboPlacebo Group2 Interventions

Subjects will participate in 3 supervised training sessions and 2 unsupervised training sessions while receiving placebo. Drug: Low Intensity Exercise + Placebo Low Intensity Exercise (LoEx) measured by a percentage of maximal heart rate in combination with placebo.

Group IV: HiEx+PlaceboPlacebo Group2 Interventions

Subjects will participate in 3 supervised training sessions and 2 unsupervised training sessions while receiving placebo. Drug: High Intensity Exercise + Placebo High Intensity Exercise (HiEx) measured by a percentage of maximal heart rate in combination with placebo.

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,152 Total Patients Enrolled

2 Trials studying Metabolic Syndrome

143 Patients Enrolled for Metabolic Syndrome

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,851,547 Total Patients Enrolled

34 Trials studying Metabolic Syndrome

19,470 Patients Enrolled for Metabolic Syndrome

Steven K Malin, PhDPrincipal InvestigatorRutgers, The State University of New Jersey

3 Previous Clinical Trials

183 Total Patients Enrolled

2 Trials studying Metabolic Syndrome

143 Patients Enrolled for Metabolic Syndrome

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04817787 — Phase 2 & 3

Metabolic Syndrome Research Study Groups: LoEx+Metformin, LoEx+Placebo, HiEx+Metformin, HiEx+Placebo

Metabolic Syndrome Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04817787 — Phase 2 & 3

Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04817787 — Phase 2 & 3

Metabolic Syndrome Patient Testimony for trial: Trial Name: NCT04817787 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the benefits of HiEx+Metformin?

"HiEx+Metformin is a medication used to treat exercise, as well as other conditions like type 1 diabetes mellitus and polycystic ovary syndrome."

Answered by AI

Are there any current vacancies in this trial for new participants?

"Yes, this information is available on clinicaltrials.gov. The trial was posted on 5/1/2021 and the listing was updated 1/12/2022."

Answered by AI

To whom does this research opportunity extend?

"The aim of this study is to enroll 80 individuals that suffer from metabolic syndrome and are between the ages of 40-80. The key inclusion criteria for potential participants are as follows: They cannot have a previous diagnosis of Type 2 diabetes, must not engage in more than 60 minutes of exercise per week, be either male or female and over 40 but under 80 years old, have an increased waist circumference (≥ 102 cm for men; ≥ 88 cm for women), and finally have a body mass index that falls between 27-47 kg/m^2."

Answered by AI

If a patient is over 35 years old, are they still eligible for this program?

"This trial is looking for patients that fall between the ages of 40 and 80. Out of the 2,772 total clinical trials on this website, 443 are for people under 18 years old and 1,329 are for patients over 65 years old."

Answered by AI

What is the current size of this clinical trial's test group?

"Yes, the trial is still recruiting patients. According to the listing on clinicaltrials.gov, the study was first posted on May 1st, 2021 and was last updated on January 12th, 2022. They are looking for a total of 80 enrollees from 3 different centers."

Answered by AI

Are there any other scientific papers which mention the combination of HiEx with Metformin?

"As of now, there are 180 clinical trials investigating the efficacy of HiEx+Metformin. Of these, 45 are in Phase 3. The majority of studies for HiEx+Metformin are located in Pittsburgh, Pennsylvania; however, there are 1952 locations operating clinical trials for HiEx+Metformin globally."

Answered by AI