Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics)

Not Applicable

• Conditions: Prediabetic State
• Interventions: Behavioral: resistance training; Behavioral: aerobic training

• Registration Number: NCT02561377
• Lead Sponsor: Nanjing University of Traditional Chinese Medicine

Brief Summary

This study evaluates the efficacy of a 12-month resistance training on metabolic control and reducing the risk of diabetes.

Detailed Description

Most of exercise interventions involved aerobic exercises, investigators were not able to find a single long term study focusing on type 2 diabetes prevention with resistance training and aerobic exercise. It has been known that for those who have already had diabetes, resistance training can reduce insulin resistance and HbA1c level, improve lipid profile, and decrease blood pressure. Based on previous findings, investigators will evaluate how the different exercising interventions impact on insulin resistance, metabolic control, and the incidence and prevalence of diabetes in prediabetes population who receive 12 months of either resistant training or aerobic exercise. Further more, metabolomics approach will be introduced to detect biological markers,and therefore,to analyze the predictive values of metabolomics on long term outcomes of prediabetes population.

Study Timeline

• Status Verified: 2015-09
• Study Start: 2015-09
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-25
• Study First Posted: 2015-09-28
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-29
• Primary Completion: 2016-07
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• a confirmed diagnosis of prediabetes according to the American Diabetes Association (ADA) guidelines
• level 4 of muscle strength
• willingness to accept exercise intervention
• provision of written informed consent.

Exclusion Criteria

• type 2 or other types of diabetes
• women who are pregnant
• hepatic dysfunction, as evidenced by alanine aminotransferase (ALT) or alkaline phosphatase (ALP) levels greater than 2.5-fold the upper limits of normal
• crucial organ failure or other severe diseases, including myocardial infarction
• malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resistance training	resistance training	Resistance training consisted of 6 different resistance exercises per session using elastic string, and each exercise progressed to 2-3 at maximum resistance lifted 8-10 times.
aerobic training	aerobic training	Aerobic training consisted of aerobic exercise and progressed from 15-20min/session at 60% maximum heart rate to 45-50min/session at 75% maximum heart rate.

Primary Outcome Measures

Name	Time	Method
glycemic control	12 months	Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 12 months.

Secondary Outcome Measures

Name	Time	Method
small molecule metabolites	12 months	Biological markers, with the method of metabolomics approach, will be measured at 12 months.
Incidence rate of diabetes	12 months	Evaluate the incidence of diabetes in prediabetes population at 12 months.

Trial Locations

Locations (2)

The first Affiliated hospital of Guangxi medical university; 🇨🇳 Nanning, Guangxi, China

Southeast University, China; 🇨🇳 Nanjing, Jiangsu, China