Study Summary
This trial will examine how 8 weeks of moderate-intensity treadmill walking affects the gut microbiome, body weight, and cardiometabolic profile of overweight or obese people with prediabetes.
Eligible Conditions
- Prediabetes
- Overweight and Obesity
- Obesity
- Type 2 Diabetes
- Type 2 Diabetes Mellitus in Obesity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: 8 weeks
8 weeks
Body Composition
C-reactive Protein (CRP)
Chain in Serum Short Chain Fatty Acids (SCFA)
Change in Shannon Index
Fasting Glucose
Fasting Insulin
Hemoglobin A1C (HbA1c)
High-density lipoprotein cholesterol (HDL-C)
Resting Blood Pressure (BP)
Triglycerides
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control Group
1 of 2
Experimental Group
1 of 2
Active Control
Experimental Treatment
100 Total Participants · 2 Treatment Groups
Primary Treatment: Physical Activity Intervention · No Placebo Group · N/A
Experimental Group
Behavioral
Experimental Group · 1 Intervention: Physical Activity Intervention · Intervention Types: BehavioralControl GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical Activity Intervention
2016
N/A
~830
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,255 Previous Clinical Trials
1,483,798 Total Patients Enrolled
Ryan Demmer, PhDPrincipal InvestigatorUniversity of Minnesota
Eligibility Criteria
Age 30 - 64 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are overweight or obese with a body mass index (BMI) of 25.0-39.
You are currently engaged in <100 min/week of physical activity.
You are willing to maintain your current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
Documentation can include either a print out or screen shot of the lab value illustrating eligibility, along with the date of the test and the participant's name
You have a stable weight over the last 6 months.
You are not currently pregnant, planning to become pregnant, or currently breastfeeding.
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Conditions
Cancer Related
Treatments