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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04931836
• Other study ID #: STUDY00009136
• Status: Completed
• Phase: N/A
• Start date: July 29, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

All eligible and consented participants will complete a 3-week run-in phase during which baseline outcome assessments will be performed. During run-in weeks 1 and 2, participants will wear a Fitbit Inspire 2 smartwatch and complete three unannounced dietary recalls. During the run-in week 3 (see table below), participants will consume their 3-day standardized meal plan on days three through five, obtain a fecal sample, complete a study questionnaire, and complete a study assessment visit. To quantify compliance with the 3-day meal plan, participants will be provided with a paper checklist of all foods to be consumed, and will be asked to indicate which foods were consumed and to document any deviation. The study assessment visit will include a fasting blood draw (at baseline and week eight only), blood pressure in triplicate, weight measure and body fat assessment in duplicate, and a saliva sample.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Overweight and Obesity
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes
• Type 2 Diabetes Mellitus
• Type 2 Diabetes Mellitus in Obese

Intervention

Behavioral:
• Physical Activity Intervention
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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Shannon Index	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
Primary	Chain 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 serum concentrations of acetate, propionate, and butyrate individually and sum of all SCFAs in units of ng/ml.	8 weeks
Secondary	High-density lipoprotein cholesterol (HDL-C)	High-density lipoprotein cholesterol (HDL-C) will be measured using standard laboratory test and report in units of mg/dl.	8 weeks
Secondary	Triglycerides	Blood triglycerides will be measured using a standard laboratory test and reported in units of mg/dl.	8 weeks
Secondary	Fasting Insulin	Fasting insulin will be measured by laboratory test and reported in units of uIU/ml.	8 weeks
Secondary	Fasting Glucose	Fasting insulin will be measured by standard laboratory test and reported in units of mg/dl.	8 weeks
Secondary	C-reactive Protein (CRP)	C-reactive protein (CRP) will be measured by laboratory test and reported in units of mg/l.	8 weeks
Secondary	Resting Blood Pressure (BP)	Resting systolic and diastolic blood pressures will be reported in units of mmHg.	8 weeks
Secondary	Hemoglobin A1C (HbA1c)	Hemoglobin A1C (HbA1c) will be measured by laboratory test. This is a unitless measure.	8 weeks
Secondary	Body Composition	Body composition will be analyzed using bioelectrical impedance. Outcome will be reported as percent body fat.	8 weeks