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Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese

Primary Purpose

PreDiabetes, Insulin Sensitivity

Status
Suspended
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
exercise intervention
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes

Eligibility Criteria

21 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

High intensity intervention

Moderate intensity intervention

non-exercise group

Arm Description

Exercise intervention at 70 to 80% of estimated heart rate maximum for 12 weeks.

Exercise intervention at 50 to 70% of estimated heart rate maximum for 12 weeks.

Participants will not receive any type of exercise training.

Outcomes

Primary Outcome Measures

change of fasting glucose
fasting glucose level

Secondary Outcome Measures

alterations of gut microbiome
advanced metagenomics to identify gut microbiota species altered by exercise training
rate of non-responsiveness in the alleviation of insulin resistance to exercise intervention
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.

Full Information

First Posted
July 27, 2017
Last Updated
May 17, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03240978
Brief Title
Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese
Official Title
An Interventional Study for the Effects of Physical Exercise on the Prevention of Prediabetes in Overweight Chinese: Role of Gut Microbiota and Adipokines
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Suspended
Study Start Date
September 2016 (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
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Overweight/obese Chinese and prediabetes will be recruited and divided into three age-matched groups including high intensity exercise, moderate intensity exercise, and non-exercise groups. The exercise program will consist of three sessions per week over the course of 12 weeks, under the supervision of our in-house exercise specialists and physiologists. The effects of exercise on glucose and lipid profiles, insulin sensitivity and adiposity will be evaluated.
Detailed Description
60 Chinese men aged between 21 and 60 years old with overweight/obesity (25 kg/m2 <BMI < 32.5 kg/m2) and prediabetes will be recruited.The participants will be divided into three age-matched groups (n=20 in each group),including high intensity exercise, moderate intensity exercise, and non-exercise groups. The suitability of each participant for physical exercise will be assessed by an in-house exercise specialist, based on parameters of blood pressure, strength, cardiovascular fitness, balance, flexibility. The exercise program will consist of three sessions per week over the course of 12 weeks, under the supervision of our in-house exercise specialists and physiologists. Each session will comprise of warm-up, resistance and aerobic training components and a cool-down. The high intensity training (aerobic combined with strength training) will consist of six exercises of three sets each, with each exercise set at an intensity of 6 to 10 repetition maximum. Intensity, volume and exercise selection will be varied both within the week and over the 12 week program in a periodised system designed to maximize muscle hypertrophy and strength gain. Exercise intensity will be at 60 to 80% of estimated heart rate maximum. Moderate intensity training (Aerobic training) will be conducted on a variety of ergometers including treadmill, cycle, rowing and cross training machines. The non-exercise group (delayed group) will be used as placebo control, and will participate in the training group at the later stage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Insulin Sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High intensity intervention
Arm Type
Experimental
Arm Description
Exercise intervention at 70 to 80% of estimated heart rate maximum for 12 weeks.
Arm Title
Moderate intensity intervention
Arm Type
Experimental
Arm Description
Exercise intervention at 50 to 70% of estimated heart rate maximum for 12 weeks.
Arm Title
non-exercise group
Arm Type
No Intervention
Arm Description
Participants will not receive any type of exercise training.
Intervention Type
Behavioral
Intervention Name(s)
exercise intervention
Intervention Description
A period of 12-week exercise intervention under the supervision of exercise specialists will be conducted.
Primary Outcome Measure Information:
Title
change of fasting glucose
Description
fasting glucose level
Time Frame
change from baseline fasting glucose level at 12 weeks
Secondary Outcome Measure Information:
Title
alterations of gut microbiome
Description
advanced metagenomics to identify gut microbiota species altered by exercise training
Time Frame
before, 4 weeks and 12 weeks after exercise training
Title
rate of non-responsiveness in the alleviation of insulin resistance to exercise intervention
Description
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.
Time Frame
before and after 12 weeks after exercise training

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimin Xu
Organizational Affiliation
Department of Medicine, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36134579
Citation
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.
Results Reference
derived
PubMed Identifier
31786155
Citation
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.
Results Reference
derived

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Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese

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