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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 June 2021
• Main ID: NCT04931836
• Date of registration: 11/06/2021
• Prospective Registration: Yes
• Primary sponsor: University of Minnesota
• Public title: The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
• Scientific title: The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
• Date of first enrolment: June 2021
• Target sample size: 100
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04931836
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Ryan Demmer, PhD

• Name: Ryan Demmer, PhD

• Name: Ryan Demmer, PhD
• Affiliation: University of Minnesota

Key inclusion & exclusion 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 Proton-Pump Inhibitors 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.



Age minimum: 30 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Overweight

Overweight and Obesity

PreDiabetes

Type 2 Diabetes

Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus in Obese

Intervention(s)

Behavioral: Physical Activity Intervention

Primary Outcome(s)

Chain in Serum Short Chain Fatty Acids (SCFA) [Time Frame: 8 weeks]

Change in Shannon Index [Time Frame: 8 weeks]

Secondary Outcome(s)

Body Composition [Time Frame: 8 weeks]

C-reactive Protein (CRP) [Time Frame: 8 weeks]

Fasting Glucose [Time Frame: 8 weeks]

Fasting Insulin [Time Frame: 8 weeks]

Hemoglobin A1C (HbA1c) [Time Frame: 8 weeks]

High-density lipoprotein cholesterol (HDL-C) [Time Frame: 8 weeks]

Resting Blood Pressure (BP) [Time Frame: 8 weeks]

Triglycerides [Time Frame: 8 weeks]

Secondary ID(s)

Demmer

Source(s) of Monetary Support

Please refer to primary and secondary sponsors