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Behavioural Intervention

Exercise + Metformin for Metabolic Syndrome

Q: Is enrollment in this trial open to individuals aged 55 or younger?

In line with the qualifications for this research investigation, individuals wishing to participate must be between 40 and 70 years old.

Q: What medical conditions are typically addressed with HiEx+metformin?

HiEx+metformin is a viable treatment option for exercise-related ailments, <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">type 1 diabetes</a> mellitus and diabetic ketoacidosis.

Q: Are there any requirements to join this clinical experimentation?

This clinical trial has a set of strict inclusion criteria which mandates that participants have metabolic syndrome and be within the ages of 40 to 70. A total of 80 individuals will be admitted into this experiment.

Q: Could you please detail other research projects that have incorporated HiEx+metformin?

Currently, 175 active clinical trials analyzing the efficacy of HiEx+metformin are running with 44 studies in Phase 3. Not only is there a cluster of research located in Rockville, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a> but 1920 other locations worldwide have launched similar investigations.

Q: Are there vacancies within this research trial for participants?

Unfortunately, this trial has already ceased accepting applicants. It was first posted on August 7th 2017 and last modified on December 6th 2022. However, if you are interested in participating in other trials related to metabolic syndrome, there are currently 1502 studies open for enrollment; HiEx+metformin has 175 different medical trials enrolling participants at the moment.

Q: How many participants are currently enrolled in this clinical trial?

Unfortunately, this trial has completed its recruitment process. It was initially posted on August 7th 2017 and last edited on December 6th 2022. However, if you are still looking for other trials there are presently 1502 studies recruiting patients with metabolic syndrome and 175 research opportunities researching HiEx+metformin that remain open to enrollment.

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

Select...

I do not have Type 2 diabetes.

Select...

I meet at least 3 of the criteria for metabolic syndrome.

Select...

I am between 40 and 70 years old.

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: 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers UniversityLead Sponsor

113 Previous Clinical Trials

2,804,013 Total Patients Enrolled

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 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

Frequently Asked Questions

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

Is enrollment in this trial open to individuals aged 55 or younger?

"In line with the qualifications for this research investigation, individuals wishing to participate must be between 40 and 70 years old."

Answered by AI

What medical conditions are typically addressed with HiEx+metformin?

"HiEx+metformin is a viable treatment option for exercise-related ailments, type 1 diabetes mellitus and diabetic ketoacidosis."

Answered by AI

Are there any requirements to join this clinical experimentation?

"This clinical trial has a set of strict inclusion criteria which mandates that participants have metabolic syndrome and be within the ages of 40 to 70. A total of 80 individuals will be admitted into this experiment."

Answered by AI

Could you please detail other research projects that have incorporated HiEx+metformin?

"Currently, 175 active clinical trials analyzing the efficacy of HiEx+metformin are running with 44 studies in Phase 3. Not only is there a cluster of research located in Rockville, Maryland but 1920 other locations worldwide have launched similar investigations."

Answered by AI

Are there vacancies within this research trial for participants?

"Unfortunately, this trial has already ceased accepting applicants. It was first posted on August 7th 2017 and last modified on December 6th 2022. However, if you are interested in participating in other trials related to metabolic syndrome, there are currently 1502 studies open for enrollment; HiEx+metformin has 175 different medical trials enrolling participants at the moment."

Answered by AI

How many participants are currently enrolled in this clinical trial?

"Unfortunately, this trial has completed its recruitment process. It was initially posted on August 7th 2017 and last edited on December 6th 2022. However, if you are still looking for other trials there are presently 1502 studies recruiting patients with metabolic syndrome and 175 research opportunities researching HiEx+metformin that remain open to enrollment."

Answered by AI

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