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

September 28, 2015 updated by: Lou Qingqing, Nanjing University of Traditional Chinese Medicine
This study evaluates the efficacy of a 12-month resistance training on metabolic control and reducing the risk of diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210096
        • Recruiting
        • Southeast University, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
No Intervention: standard care
standard care complied with the daily lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glycemic control
Time Frame: 6 months
Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 6 months.
6 months
glycemic control
Time Frame: 12 months
Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
small molecule metabolites
Time Frame: 6 months
Biological markers, with the method of metabolomics approach, will be measured at 6 months
6 months
small molecule metabolites
Time Frame: 12 months
Biological markers, with the method of metabolomics approach, will be measured at 12 months.
12 months
Incidence rate of diabetes
Time Frame: 6 months
Evaluate the incidence of diabetes in prediabetes population at 6 months.
6 months
Incidence rate of diabetes
Time Frame: 12 months
Evaluate the incidence of diabetes in prediabetes population at 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University of Traditional Chinese Medicine

Collaborators

Guangxi Medical University
Southeast University, China

Investigators

  • Study Director: Qingqing Lou, Nanjing University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81370923

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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