PreDiabetesNCT04124354
Influence of Exercise on the Gut Microbiome of Overweight and Obese Adults With Prediabetes
A study testing Physical Activity in people with PreDiabetes, run by University of Minnesota at 1 site in United States.
Trial summary
Purpose: The investigators propose a 20-participant randomized 2-arm parallel trial with a delayed-intervention control examining how 8 weeks of moderate-intensity walking exercise alters the gut microbiome, short chain fatty acid (SCFA)-producing taxa, and the cardiometabolic profile and body weight of individuals… Read more about this study
- Who is it for?
- Ages 30 to 64 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Classified as overweight or obese with BMI 25.0-39.9 kg/m2
- Diagnosis of prediabetes as classified by a fasted blood glucose of 100 - 125 mg/dL, 2-hour oral glucose tolerance test of 140 - 199 mg/dL, or HbA1C level of 5.7% - 6.5%
- Currently engaged in < 150 minutes/week of physical activity-confirmed via the Modifiable Activity Questionnaire
Who cannot join
- Individuals with contraindications to exercise participation as assessed by the Physical Activity Readiness Questionnaire
- Self-reported physical/mental disabilities or gastrointestinal conditions
- Antibiotic usage within the last 45 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Epidemiology Clinical Research Center
Minneapolis, Minnesota, 55455
About this study
Purpose: The investigators propose a 20-participant randomized 2-arm parallel trial with a delayed-intervention control examining how 8 weeks of moderate-intensity walking exercise alters the gut microbiome, short chain fatty acid (SCFA)-producing taxa, and the cardiometabolic profile and body weight of individuals who are overweight or obese and have prediabetes (PreD).
Aim 1: Examine and compare exercise-related shifts in the gut microbiome of individuals with PreD.
Read more
Aim 2: Examine and compare exercise-related changes in SCFA-producing taxa.
Exploratory Aim: Examine what percentage of the exercise-related changes observed in participants' gut microbiome and SCFA-producing taxa mediate changes in their cardiometabolic profile and body weight.
Read the detailed description
In the U.S, 91.8 million adults have PreD. Preventing progression of PreD to type 2 diabetes (T2D) is vital. Odds of cardiovascular disease are higher among those with T2D, with $327 billion/year spent treating T2D. Major scientific organizations have thus called for studies of novel intermediates connecting health behaviors to pre-clinical cardiometabolic disease (CMD; e.g., PreD) to lower future clinical disease risk. Physical activity (PA) is key modifiable determinant of good health. PA recommendation adherence is associated with a 25-35% dose-dependent reduction in all-cause mortality, with as little as 75 min/week of regular moderate-intensity PA beneficial. In fact, an intervention within the Diabetes Prevention Program emphasizing PA participation at recommended levels was as successful as Metformin in preventing incident T2D-likely partially due to a 5kg-reduction in body weight during this trial. Yet, PA's impact on disease risk reduction is not explained entirely by CMD risk factors or weight loss, with mechanistic pathways still unclear and crucial to examine. The gut microbiota and microbiome have been posited as mechanistic intermediates linking PA to attenuated CMD development. However, there is no known research which has examined exercise-related changes in the human gut microbiome or SCFA-producing taxa in a population with a pre-clinical CMD such as PreD and how these changes mediate changes in CMD indices and body weight.
The proposed project is therefore innovative for a least two reasons. First, as stated, the investigators know of no study in individuals with PreD which examined how a moderate-intensity walking program may modify the gut microbiome and SCFA-producing taxa. Second, the investigators will use formal mediation analyses to examine the degree to which exercise-related changes in the gut microbiome and SCFA-producing taxa explain changes observed in CMD indices and body weight. These exploratory analyses will allow for a deeper interpretation of the physiological mechanisms by which exercise may improve health and inform future trial construction. Indeed, this study will provide critical preliminary evidence for a larger NIH R01-funded trial submitted to the NIDDK, NHLBI, or NCI, with the NIH committed to funding innovative scientific proposals involving the microbiome. The investigators will use this trial's observations to determine: 1) which taxa within the gut microbiome are most impacted by moderate-intensity walking; 2) the intra- and inter-person variability of gut microbiota changes due to moderate-intensity walking; and 3) whether the fixed frequency, intensity, and duration of the walking implemented results in meaningful changes. Observations in relation to these points will inform the design and implementation of future interventions to reduce pre-clinical disease states like PreD in a mechanistically-informed manner.
- Conditions
- PreDiabetes
- Being tested
- Physical Activity
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Participants will attend 3 treadmill walking sessions/week for 8 weeks (24 total)-exercising at 60-75% of their heart rate (HR) reserve monitored using Polar FT1 HR monitors. All walking sessions will take place using treadmills within the West Bank Office Building on the UMN-Twin Cities campus. Each walking session will be 30 min long during intervention weeks 1-4 and 45 min each during weeks 5-8. This exercise dose is equivalent to that employed in the only two human studies of exercise and the gut microbiome in addition to the dosage observed necessary to yield meaningful cardiometabolic changes. After the 4th- and 8th-weeks of the intervention, participants in both study groups will again undergo outcome assessments
| Study group | Role | What they receive |
|---|---|---|
| Immediate Experimental Group | Experimental | Participants will immediately begin an experimental supervised moderate-intensity treadmill walking intervention program. Receives: Behavioral: Physical Activity |
| Delayed Intervention Control Group | No intervention | Participants will be asked to maintain their usual physical activity during the initial 8-week intervention period but will undergo all data collection procedures. Following the initial intervention period, these participants will be given the option to complete the 8-week intervention, with identical data collection procedures employed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shannon Index (Alpha-Diversity) as Reflected in Change in Operational Taxonomic Units
Alpha diversity is the mean species diversity of a local site, which, in this study, is the fecal sample provided by participants used as a proxy for sampling the gut microbiome. The Shannon Index is based on the weighted geometric mean of the proportional abundances of the types of microbes. Change in alpha diversity will be reported as change in operational taxonomic units (OTUs).
Measured: Baseline, 8 weeks
Secondary outcomes (11)
Change in Plasma LDL Concentrations
Participants will have blood drawn after fasting over night or for at least 8 hours. Plasma low density lipoprotein (LDL) concentrations will be determined using standard laboratory assay methods. Concentrations will be reported in mg/dl.
Measured: Baseline, 8 weeks
Change in Plasma HDL Concentrations
Participants will have blood drawn after fasting over night or for at least 8 hours. Plasma high density lipoprotein (HDL) concentrations will be determined using standard laboratory assay methods. Concentrations will be reported in mg/dl.
Measured: Baseline, 8 weeks
Change in Plasma Total Cholesterol Concentrations
Participants will have blood drawn after fasting over night or for at least 8 hours. Plasma total cholesterol concentrations will be determined using standard laboratory assay methods. Concentrations will be reported in mg/dl.
Measured: Baseline, 8 weeks
Change in Plasma Insulin Concentrations
Participants will have blood drawn after fasting over night or for at least 8 hours. Plasma insulin concentrations will be determined using standard laboratory assay methods. Concentrations will be reported in mmol/l.
Measured: Baseline, 8 weeks
Change in Plasma Glucose Concentrations
Participants will have blood drawn after fasting over night or for at least 8 hours. Plasma glucose concentrations will be determined using standard laboratory assay methods. Concentrations will be reported in mg/dl.
Measured: Baseline, 8 weeks
Change in Plasma CRP Concentrations
Participants will have blood drawn after fasting over night or for at least 8 hours. Plasma C-reactive protein (CRP) concentrations will be determined using standard laboratory assay methods. Concentrations will be reported in mg/l.
Measured: Baseline, 8 weeks
Change in Resting Blood Pressure - Systolic
Resting blood pressure will be measured using an Omron Automatic BP Cuff and reported in mmHG.
Measured: Baseline, 8 weeks
Change in Resting Blood Pressure - Diastolic
Resting blood pressure will be measured using an Omron Automatic BP Cuff and reported in mmHG.
Measured: Baseline, 8 weeks
Change in Waist Circumference
Waist circumference will be measured using anthropometric tape and reported in cm.
Measured: Baseline, 8 weeks
Change in Body Weight
Body weight will be measured using a Tanita Body Composition and Weight scale and reported in kg.
Measured: Baseline, 8 weeks
Change in Body Fat Percentage
Body fat percentage will be measured using a Tanita Body Composition and Weight scale and reported as a percentage.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start10 Feb 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: Only 4 participants completed due to COVID-19 and the many lockdowns. We received a NIH R21 to complete a larger version of this trial and are working on launching this larger trial and submitting it to ClinicalTrials.gov.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124354
- Sponsor's protocol ID
- STUDY00007532
- Status last verified
- Jul 2021
- First submitted
- 10 Oct 2019
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Exercise on the Gut Microbiome of Overweight and Obese Adults With Prediabetes
- ClinicalTrials.gov ID
- NCT04124354
- Acronym / sponsor ID
- STUDY00007532
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only 4 participants completed due to COVID-19 and the many lockdowns. We received a NIH R21 to complete a larger version of this trial and are working on launching this larger trial and submitting it to ClinicalTrials.gov.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The investigators propose a 20-participant randomized 2-arm parallel trial with a delayed-intervention control examining how 8 weeks of moderate-intensity walking exercise alters the gut microbiome, short chain fatty acid (SCFA)-producing taxa, and the cardiometabolic profile and body weight of individuals who are overweight or obese and have prediabetes (PreD).
Aim 1: Examine and compare exercise-related shifts in the gut microbiome of individuals with PreD.
Aim 2: Examine and compare exercise-related changes in SCFA-producing taxa.
Exploratory Aim: Examine what percentage of the exercise-related changes observed in participants' gut microbiome and SCFA-producing taxa mediate changes in their cardiometabolic profile and body weight.
Detailed description
In the U.S, 91.8 million adults have PreD. Preventing progression of PreD to type 2 diabetes (T2D) is vital. Odds of cardiovascular disease are higher among those with T2D, with $327 billion/year spent treating T2D. Major scientific organizations have thus called for studies of novel intermediates connecting health behaviors to pre-clinical cardiometabolic disease (CMD; e.g., PreD) to lower future clinical disease risk. Physical activity (PA) is key modifiable determinant of good health. PA recommendation adherence is associated with a 25-35% dose-dependent reduction in all-cause mortality, with as little as 75 min/week of regular moderate-intensity PA beneficial. In fact, an intervention within the Diabetes Prevention Program emphasizing PA participation at recommended levels was as successful as Metformin in preventing incident T2D-likely partially due to a 5kg-reduction in body weight during this trial. Yet, PA's impact on disease risk reduction is not explained entirely by CMD risk factors or weight loss, with mechanistic pathways still unclear and crucial to examine. The gut microbiota and microbiome have been posited as mechanistic intermediates linking PA to attenuated CMD development. However, there is no known research which has examined exercise-related changes in the human gut microbiome or SCFA-producing taxa in a population with a pre-clinical CMD such as PreD and how these changes mediate changes in CMD indices and body weight.
The proposed project is therefore innovative for a least two reasons. First, as stated, the investigators know of no study in individuals with PreD which examined how a moderate-intensity walking program may modify the gut microbiome and SCFA-producing taxa. Second, the investigators will use formal mediation analyses to examine the degree to which exercise-related changes in the gut microbiome and SCFA-producing taxa explain changes observed in CMD indices and body weight. These exploratory analyses will allow for a deeper interpretation of the physiological mechanisms by which exercise may improve health and inform future trial construction. Indeed, this study will provide critical preliminary evidence for a larger NIH R01-funded trial submitted to the NIDDK, NHLBI, or NCI, with the NIH committed to funding innovative scientific proposals involving the microbiome. The investigators will use this trial's observations to determine: 1) which taxa within the gut microbiome are most impacted by moderate-intensity walking; 2) the intra- and inter-person variability of gut microbiota changes due to moderate-intensity walking; and 3) whether the fixed frequency, intensity, and duration of the walking implemented results in meaningful changes. Observations in relation to these points will inform the design and implementation of future interventions to reduce pre-clinical disease states like PreD in a mechanistically-informed manner.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Experimental Group | Experimental | Behavioral: Physical ActivityParticipants will immediately begin an experimental supervised moderate-intensity treadmill walking intervention program. |
| Delayed Intervention Control Group | No intervention | –Participants will be asked to maintain their usual physical activity during the initial 8-week intervention period but will undergo all data collection procedures. Following the initial intervention period, these participants will be given the option to complete the 8-week intervention, with identical data collection procedures employed. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Classified as overweight or obese with BMI 25.0-39.9 kg/m2
- Diagnosis of prediabetes as classified by a fasted blood glucose of 100 - 125 mg/dL, 2-hour oral glucose tolerance test of 140 - 199 mg/dL, or HbA1C level of 5.7% - 6.5%
- Currently engaged in < 150 minutes/week of physical activity-confirmed via the Modifiable Activity Questionnaire
Key exclusion criteria (3 listed)
- Individuals with contraindications to exercise participation as assessed by the Physical Activity Readiness Questionnaire
- Self-reported physical/mental disabilities or gastrointestinal conditions
- Antibiotic usage within the last 45 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityParticipants will attend 3 treadmill walking sessions/week for 8 weeks (24 total)-exercising at 60-75% of their heart rate (HR) reserve monitored using Polar FT1 HR monitors. All walking sessions will take place using treadmills within the West Bank Office Building on the UMN-Twin Cities campus. Each walking session will be 30 min long during intervention weeks 1-4 and 45 min each during weeks 5-8. This exercise dose is equivalent to that employed in the only two human studies of exercise and the gut microbiome in addition to the dosage observed necessary to yield meaningful cardiometabolic changes. After the 4th- and 8th-weeks of the intervention, participants in both study groups will again undergo outcome assessments | Behavioural | Immediate Experimental Group |
Primary outcome
Change in Shannon Index (Alpha-Diversity) as Reflected in Change in Operational Taxonomic Units
Time frame: Baseline, 8 weeks
Alpha diversity is the mean species diversity of a local site, which, in this study, is the fecal sample provided by participants used as a proxy for sampling the gut microbiome. The Shannon Index is based on the weighted geometric mean of the proportional abundances of the types of microbes. Change in alpha diversity will be reported as change in operational taxonomic units (OTUs).
11 secondary outcomes
Change in Plasma LDL Concentrations
Time frame: Baseline, 8 weeks
Change in Plasma HDL Concentrations
Time frame: Baseline, 8 weeks
Change in Plasma Total Cholesterol Concentrations
Time frame: Baseline, 8 weeks
Change in Plasma Insulin Concentrations
Time frame: Baseline, 8 weeks
Change in Plasma Glucose Concentrations
Time frame: Baseline, 8 weeks
Change in Plasma CRP Concentrations
Time frame: Baseline, 8 weeks
Change in Resting Blood Pressure - Systolic
Time frame: Baseline, 8 weeks
Change in Resting Blood Pressure - Diastolic
Time frame: Baseline, 8 weeks
Change in Waist Circumference
Time frame: Baseline, 8 weeks
Change in Body Weight
Time frame: Baseline, 8 weeks
Change in Body Fat Percentage
Time frame: Baseline, 8 weeks
Results and safety
The study was stopped early (reason given: Only 4 participants completed due to COVID-19 and the many lockdowns. We received a NIH R21 to complete a larger version of this trial and are working on launching this larger trial and submitting it to ClinicalTrials.gov.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for PreDiabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with PreDiabetes, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Only 4 participants completed due to COVID-19 and the many lockdowns. We received a NIH R21 to complete a larger version of this trial and are working on launching this larger trial and submitting it to ClinicalTrials.gov.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shannon Index (Alpha-Diversity) as Reflected in Change in Operational Taxonomic Units (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.