- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03240978
Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese
An Interventional Study for the Effects of Physical Exercise on the Prevention of Prediabetes in Overweight Chinese: Role of Gut Microbiota and Adipokines
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- Department of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- overweight/obese Chinese man (25 kg/m2<BMI<32.5 kg/m2) aged between 21 and 60 years old; prediabetes, impaired glucose tolerance (mean 2-h blood glucose ≥7.8 and ≤11.1 mmol/l after a 75-g oral glucose challenge) or impaired fasting glucose (mean fasting blood glucose ≥6.1 mmol/l and ≤7.0 mmol/l and HbA1c levels between 5.7% and 6.4%).
Exclusion Criteria:
- any neurological, musculoskeletal or cardio respiratory condition, which would put them at risk during exercise or inhibit their ability to adapt to an exercise program; any subject participated in a regular vigorous exercise and/or diet program more than 2 times per week in the 3 months prior to recruitment; any subject who is taking medicine, especially antibiotics in the past week prior to study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High intensity intervention
Exercise intervention at 70 to 80% of estimated heart rate maximum for 12 weeks.
|
A period of 12-week exercise intervention under the supervision of exercise specialists will be conducted.
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Experimental: Moderate intensity intervention
Exercise intervention at 50 to 70% of estimated heart rate maximum for 12 weeks.
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A period of 12-week exercise intervention under the supervision of exercise specialists will be conducted.
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No Intervention: non-exercise group
Participants will not receive any type of exercise training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of fasting glucose
Time Frame: change from baseline fasting glucose level at 12 weeks
|
fasting glucose level
|
change from baseline fasting glucose level at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
alterations of gut microbiome
Time Frame: before, 4 weeks and 12 weeks after exercise training
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advanced metagenomics to identify gut microbiota species altered by exercise training
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before, 4 weeks and 12 weeks after exercise training
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rate of non-responsiveness in the alleviation of insulin resistance to exercise intervention
Time Frame: before and after 12 weeks after exercise training
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Participants in the exercise arms are further classified into responders or non-responsders, depending on whether they could demonstrate a decrease of insulin resistance index (HOMA-IR) greater than 2-fold technical error, which is a threshold for true physiological adaptation.
HOMA-IR is calculated using homeostasis model assessment methods, defined as fasting insulin (μU/mL)×fasting glucose (mmol/L)/22.5.
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before and after 12 weeks after exercise training
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aimin Xu, Department of Medicine, the University of Hong Kong
Publications and helpful links
General Publications
- Jin L, Geng L, Ying L, Shu L, Ye K, Yang R, Liu Y, Wang Y, Cai Y, Jiang X, Wang Q, Yan X, Liao B, Liu J, Duan F, Sweeney G, Woo CWH, Wang Y, Xia Z, Lian Q, Xu A. FGF21-Sirtuin 3 Axis Confers the Protective Effects of Exercise Against Diabetic Cardiomyopathy by Governing Mitochondrial Integrity. Circulation. 2022 Nov 15;146(20):1537-1557. doi: 10.1161/CIRCULATIONAHA.122.059631. Epub 2022 Sep 22.
- Liu Y, Wang Y, Ni Y, Cheung CKY, Lam KSL, Wang Y, Xia Z, Ye D, Guo J, Tse MA, Panagiotou G, Xu A. Gut Microbiome Fermentation Determines the Efficacy of Exercise for Diabetes Prevention. Cell Metab. 2020 Jan 7;31(1):77-91.e5. doi: 10.1016/j.cmet.2019.11.001. Epub 2019 Nov 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW-15370
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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