The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults

NCT04931836 | Completed Results

• 1 other identifier: STUDY00009136
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Overweight; Overweight and Obesity; PreDiabetes; Type 2 Diabetes; Type 2 Diabetes Mellitus; Type 2 Diabetes Mellitus in Obese

Keywords

Microbiome; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Change in Shannon Index (Unitless)

  Changes to the gut microbiome will be assessed via metagenomic sequencing, from pre- to post-intervention. The Shannon Index-a measure of microbial community diversity-will be the primary indicator for changes in gut microbiota composition, and will be assessed at baseline, and following the 4th and 8th weeks. Index values are unitless and range from 0 to 1. Lower values indicate more diversity while higher values indicate less diversity. Outcome will be reported at baseline, 4 weeks, and 8 weeks and as the change from baseline to 4 weeks and baseline to 8 weeks.

  8 weeks

• Change in Serum Short Chain Fatty Acids (SCFA)

  Participants will undergo fasted blood draws to assess serum SCFA levels. This work will be performed using the Metabolon pipeline. Outcome is reported as the sum of the serum concentrations of acetate, propionate, and butyrate in Z-score units. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values. The original units are reported in ng/mL and the final results are reported as standardized z-scores in which each value subtracts the mean and the difference is divided by the standard deviation. Higher values represent higher levels of SCFA which is considered better. The scale is in standard deviation units. A value of 0 = the population mean.

  8 weeks

Secondary Outcomes (8)

• High-density Lipoprotein Cholesterol (HDL-C)

  8 weeks

• Triglycerides

  8 weeks

• Fasting Insulin

  8 weeks

• Fasting Glucose

  8 weeks

• C-reactive Protein (CRP)

  8 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in this group will complete the physical activity intervention.

Behavioral: Physical Activity Intervention

Control Group

NO INTERVENTION

Participants in this group will be asked to maintain their normal level of physical activity.

Interventions

Physical Activity Intervention BEHAVIORAL

Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions will either take place on new commercial treadmills in the Epidemiology Clinical Research Center or remotely at or around a participant's home. Regardless of the walking location, walking sessions will be 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.

Experimental Group

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Self-reported use of metformin and/or other medications that could interfere with the primary outcome.
• History of bariatric surgery or a history of other medical interventions that would interfere with the primary outcome.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Prediabetic State; Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Results Point of Contact

• Title: Mark Pereira, PhD
• Organization: University of Minnesota

map@umn.edu

612-624-4173

Study Officials

• Ryan Demmer, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: July 29, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-06

Locations

US (1)