Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese

NCT ID: NCT03240978

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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PreDiabetes Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High intensity intervention

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

Group Type EXPERIMENTAL

exercise intervention

Intervention Type BEHAVIORAL

A period of 12-week exercise intervention under the supervision of exercise specialists will be conducted.

Moderate intensity intervention

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

Group Type EXPERIMENTAL

exercise intervention

Intervention Type BEHAVIORAL

A period of 12-week exercise intervention under the supervision of exercise specialists will be conducted.

non-exercise group

Participants will not receive any type of exercise training.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise intervention

A period of 12-week exercise intervention under the supervision of exercise specialists will be conducted.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aimin Xu

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, The University of Hong Kong

Locations

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Department of Medicine

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Wang Y, Chen J, Ni Y, Liu Y, Gao X, Tse MA, Panagiotou G, Xu A. Exercise-changed gut mycobiome as a potential contributor to metabolic benefits in diabetes prevention: an integrative multi-omics study. Gut Microbes. 2024 Jan-Dec;16(1):2416928. doi: 10.1080/19490976.2024.2416928. Epub 2024 Oct 29.

Reference Type DERIVED
PMID: 39473051 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36134579 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31786155 (View on PubMed)

Other Identifiers

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UW-15370

Identifier Type: -

Identifier Source: org_study_id

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