Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese

PreDiabetes Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03240978
• Other study ID #: UW-15370
• Status: Suspended
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

60 Chinese men aged between 21 and 60 years old with overweight/obesity (25 kg/m2

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Insulin Resistance
• Insulin Sensitivity
• Overweight
• PreDiabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Department of Medicine	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of fasting glucose	fasting glucose level	change from baseline fasting glucose level at 12 weeks
Secondary	alterations of gut microbiome	advanced metagenomics to identify gut microbiota species altered by exercise training	before, 4 weeks and 12 weeks after exercise training
Secondary	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.	before and after 12 weeks after exercise training