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Weight loss with diet with exercise for Insulin Resistance (PE Trial)

N/A
Waitlist Available
Led By Samuel Klein, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 4 months from baseline testing to 7-10% weight loss
Awards & highlights

PE Trial Summary

This study is evaluating whether a very low fat plant-based diet with an exercise program can improve metabolic and cardiovascular health in overweight adults at high risk for disease.

Eligible Conditions
  • Insulin Resistance
  • Obesity

PE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 4 months from baseline testing to 7-10% weight loss
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 4 months from baseline testing to 7-10% weight loss 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 insulin sensitivity
Secondary outcome measures
Change in 24 hour glucose concentrations with feeding
Change in 24 hour hormone concentrations with feeding
Change in 24 hour metabolite concentrations with feeding
+15 more

PE Trial Design

1Treatment groups
Experimental Treatment
Group I: Weight loss with diet with exerciseExperimental Treatment1 Intervention
Persons with obesity with blood glucose concentrations higher than recommended and a moderate to high amount of fat in the liver (people with metabolically abnormal obesity) will be tested before and after ~7-10% weight loss. Following baseline testing, participants will be placed on a caloric-restricted plant-based very-low-fat (PB) diet and an exercise program until ~7-10% weight loss is achieved; they will then be re-tested so that pre- and post-intervention outcomes can be compared.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,694 Total Patients Enrolled
20 Trials studying Insulin Resistance
1,346 Patients Enrolled for Insulin Resistance
The Foundation for Barnes-Jewish HospitalOTHER
37 Previous Clinical Trials
6,773 Total Patients Enrolled
Samuel Klein, MDPrincipal InvestigatorWashington University School of Medicine
27 Previous Clinical Trials
2,213 Total Patients Enrolled
6 Trials studying Insulin Resistance
677 Patients Enrolled for Insulin Resistance

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Effects of a Calorie Restricted, Very Low Fat Plant-based Diet and Multi-component Exercise Program on Metabolic Health
2016. "Effects of a Calorie Restricted, Very Low Fat Plant-based Diet and Multi-component Exercise Program on Metabolic Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02706288.
~1 spots leftby Apr 2025
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