NCT03240978

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

7.3 years

First QC Date

July 27, 2017

Last Update Submit

May 17, 2022

Conditions

PreDiabetesInsulin Sensitivity

Outcome Measures

Primary Outcomes (1)

  • change of fasting glucose

    fasting glucose level

    change from baseline fasting glucose level at 12 weeks

Secondary Outcomes (2)

  • alterations of gut microbiome

    before, 4 weeks and 12 weeks after exercise training

  • rate of non-responsiveness in the alleviation of insulin resistance to exercise intervention

    before and after 12 weeks after exercise training

Study Arms (3)

High intensity intervention

EXPERIMENTAL

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

Behavioral: exercise intervention

Moderate intensity intervention

EXPERIMENTAL

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

Behavioral: exercise intervention

non-exercise group

NO INTERVENTION

Participants will not receive any type of exercise training.

Interventions

exercise interventionBEHAVIORAL

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

High intensity interventionModerate intensity intervention

Eligibility Criteria

Age21 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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%).

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine

Hong Kong, Hong Kong

Location

Related Publications (3)

  • 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.

    PMID: 39473051DERIVED

  • 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.

    PMID: 36134579DERIVED

  • 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.

    PMID: 31786155DERIVED

MeSH Terms

Conditions

Prediabetic StateInsulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Aimin Xu

    Department of Medicine, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 7, 2017

Study Start

September 1, 2016

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)