Back to resultsThe Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
Primary Purpose
Obesity, Overweight, Overweight and Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity Intervention
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Microbiome, Physical Activity
Eligibility Criteria
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.
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
Participants in this group will complete the physical activity intervention.
Participants in this group will be asked to maintain their normal level of physical activity.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Triglycerides
Blood triglycerides will be measured using a standard laboratory test and reported in units of mg/dl.
Fasting Insulin
Fasting insulin will be measured by laboratory test and reported in units of uIU/ml.
Fasting Glucose
Fasting insulin will be measured by standard laboratory test and reported in units of mg/dl.
C-reactive Protein (CRP)
C-reactive protein (CRP) will be measured by laboratory test and reported in units of mg/l.
Resting Blood Pressure (BP)
Resting systolic and diastolic blood pressures will be reported in units of mmHg.
Hemoglobin A1C (HbA1c)
Hemoglobin A1C (HbA1c) will be measured by laboratory test. This is a unitless measure.
Body Composition
Body composition will be analyzed using bioelectrical impedance. Outcome will be reported as percent body fat.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04931836
Brief Title
The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
Official Title
The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Overweight and Obesity, PreDiabetes, Type 2 Diabetes, Type 2 Diabetes Mellitus, Type 2 Diabetes Mellitus in Obese
Keywords
Microbiome, Physical Activity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Participants in this group will complete the physical activity intervention.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in this group will be asked to maintain their normal level of physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Shannon Index
Description
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.
Time Frame
8 weeks
Title
Chain in Serum Short Chain Fatty Acids (SCFA)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
High-density lipoprotein cholesterol (HDL-C)
Description
High-density lipoprotein cholesterol (HDL-C) will be measured using standard laboratory test and report in units of mg/dl.
Time Frame
8 weeks
Title
Triglycerides
Description
Blood triglycerides will be measured using a standard laboratory test and reported in units of mg/dl.
Time Frame
8 weeks
Title
Fasting Insulin
Description
Fasting insulin will be measured by laboratory test and reported in units of uIU/ml.
Time Frame
8 weeks
Title
Fasting Glucose
Description
Fasting insulin will be measured by standard laboratory test and reported in units of mg/dl.
Time Frame
8 weeks
Title
C-reactive Protein (CRP)
Description
C-reactive protein (CRP) will be measured by laboratory test and reported in units of mg/l.
Time Frame
8 weeks
Title
Resting Blood Pressure (BP)
Description
Resting systolic and diastolic blood pressures will be reported in units of mmHg.
Time Frame
8 weeks
Title
Hemoglobin A1C (HbA1c)
Description
Hemoglobin A1C (HbA1c) will be measured by laboratory test. This is a unitless measure.
Time Frame
8 weeks
Title
Body Composition
Description
Body composition will be analyzed using bioelectrical impedance. Outcome will be reported as percent body fat.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Demmer, PhD
Phone
612-626-8597
Email
demm0009@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Demmer, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Demmer, PhD
12. IPD Sharing Statement
Learn more about this trial
The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
We'll reach out to this number within 24 hrs