Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese

Not Applicable

Suspended

• Conditions: PreDiabetes; Insulin Sensitivity
• Interventions: Behavioral: exercise intervention

• Registration Number: NCT03240978
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Moderate intensity intervention	exercise intervention	Exercise intervention at 50 to 70% of estimated heart rate maximum for 12 weeks.
High intensity intervention	exercise intervention	Exercise intervention at 70 to 80% of estimated heart rate maximum for 12 weeks.

Primary Outcome Measures

Name	Time	Method
change of fasting glucose	change from baseline fasting glucose level at 12 weeks	fasting glucose level

Secondary Outcome Measures

Name	Time	Method
rate of non-responsiveness in the alleviation of insulin resistance to exercise intervention	before and after 12 weeks after exercise training	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.
alterations of gut microbiome	before, 4 weeks and 12 weeks after exercise training	advanced metagenomics to identify gut microbiota species altered by exercise training

Trial Locations

Locations (1)

Department of Medicine; 🇭🇰 Hong Kong, Hong Kong