NCT04931836Completed
The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
Source: ClinicalTrials.gov · Last updated 13 Jun 2025
Brief summary (registry, in English)
The present study is a 100-participant randomized controlled 2-arm parallel trial that employs a metagenomic approach to examine how 8 weeks of supervised moderate-intensity treadmill walking exercise (MWE) for 30-45 min 3 times/week alters the gut microbiome, serum short chain fatty acids, and the cardiometabolic profile, body weight, and body composition of individuals 30-64 years old who have overweight or obesity and have prediabetes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 77 (actual)
- First submitted
- 11 Jun 2021
- Start date
- 29 Jul 2021
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- University of Minnesota
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT04931836
What you commit to
- Study type: Interventional
- Participants enrolled: 77
- From 29 Jul 2021 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Self-reported use of metformin and/or other medications that could interfere with the primary outcome.
Other illness
- History of bariatric surgery or a history of other medical interventions that would interfere with the primary outcome.
Who the study is looking for
- Classified as overweight or obese with BMI 25.0-39.9 kg/m2.
- Documentation\* of a prediabetes diagnosis within one year of enrollment by physician or primary care provider based on lab tests showing a fasted blood glucose of 100-125 mg/dL, a 2-hour oral glucose tolerance test of 140-199 mg/dL, or an HbA1c level of 5.7%-6.4%76; OR a study screening lab value of HbA1C within the afore mentioned range.
- Currently engaged in \<100 min/week of physical activity - confirmed by questionnaire.
- No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)78-this Questionnaire involves seven "yes" or "no" questions regarding an individual's health status, with answering "yes" to any one of these questions requiring a prospective participant to acquire a written doctor's note stating they can safely participate in the trial's exercise intervention.
- No self-reported physical/mental disabilities or gastrointestinal conditions.
- No antibiotic usage within the last 45 days.
- Stable weight over the last 6 months (\<10% change).
- Not currently pregnant, planning to become pregnant, or currently breastfeeding.
- Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
- Note: 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. If a hard copy is provided, the date and name will be redacted.
Age in the registry: 30 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.