Long-term Effect of Moderate and Vigorous Exercise on Incident Diabetes in Obese Subjects

June 5, 2023 updated by: Xiaoying Li, Shanghai Zhongshan Hospital

Effect of Moderate and Vigorous Exercise on Incident Diabetes in Central Obese Subjects: a 10-year Follow-up Study

Our previous randomized controlled trial has recruited 220 subjects with central obesity and allocated the subjects to the non-exercise control, moderate exercise and vigorous exercise groups. The purpose of our previous study was to investigate the effect of moderate and vigorous exercise on improvement of fatty liver. Those subjects will be followed up for incident diabetes at 2 year and 10 year since randomization. The subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our previous randomized controlled trial has recruited 220 subject with central obesity and NAFLD. Those subjects were allocated into non-exercise control, moderate exercise and vigorous exercise groups, who received lifestyle education alone, moderate intensity exercise and vigorous intensity exercise, respectively. The exercise intervention lasted one year. Those three group subjects will be followed up and evaluated for incident diabetes at 2 year and 10 year since randomization. All the subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.

Study Type

Observational

Enrollment (Actual)

220

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The participants in our study included all subjects who had been enrolled in the previous randomized controlled trial.

Description

Inclusion criteria

  1. Subjects with NAFLD determined by 1H MRS (intrahepatic triglyceride content ≥5%);
  2. 40-65 years old;
  3. Waist circumference >90cm for men and >85cm for women

Exclusion criteria

  1. Consumed more than an average of 140 grams of ethanol (10 alcoholic drinks) per week in men and 70 grams of ethanol (five drinks) in women during the past six months;
  2. A history of acute or chronic viral hepatitis, drug-induced liver diseases, and autoimmune hepatitis;
  3. Myocardial infarction in the past six months;
  4. Biliary obstructive diseases;
  5. Uncontrolled hypertension (i.e. systolic BP>180 mmHg, and/or diastolic DBP >100 mmHg);
  6. Chronic kidney disease (serum creatinine ≥1.5 mg/dL in men and ≥1.3 mg/dL in women);
  7. Heart failure (New York Heart Association III or IV);
  8. Currently participating in weight loss programs;
  9. Currently pregnant or planning to be pregnant;
  10. Having any medical condition that would affect metabolism (i.e. diabetes, known hyperthyroidism or hypothyroidism);
  11. Having a medical condition that would limit exercise participation and taking medication that would affect metabolism or weight loss (i.e. thyroid medication and glucocorticoids) or would alter the heart rate response during exercise (i.e. β-blockers);
  12. Unable to participate in the follow-up examination.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non exercise program
Subjects receive 12 month lifestyle education alone.
Behavioral: Non-exercise control
12 month lifestyle education
Moderate intensity exercise program
Subjects receive 12 month moderate exercise.
Behavioral: Moderate intensity exercise
12 month moderate intensity exercise by brisk walk 30 min per day and more than 5 days per week.
Vigorous intensity exercise program
Subjects receive 6 month vigorous exercise and subsequent 6 month moderate exercise
Behavioral: Vigorous intensity exercise
6 month vigorous intensity exercise on treadmill for 30 min per day and more than 5 days per week, and subsequent 6 month moderate exercise by brisk walk 30 min per day and more than 5 days per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of type 2 diabetes
Time Frame: 10 years since randomization
The occurrence of diabetes at 2- and 10-year follow-up
10 years since randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight change
Time Frame: 10 years since randomization
Body weight change at 2 and 10 year follow-up
10 years since randomization
Blood pressure change
Time Frame: 10 years since randomization
Systolic and diastolic blood pressure at 2- and 10-year follow-up
10 years since randomization
Serum lipid change
Time Frame: 10 years since randomization
Serum triglyceride, LDL-c levels at 2- and 10- year follow-up
10 years since randomization

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Xiaoying Li, MD, Fudan University

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 (Actual)

July 1, 2011

Primary Completion (Actual)

May 15, 2022

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCEMD011V2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

deidentified data will be available after approval of the proposal

IPD Sharing Time Frame

2023-01~2025-01

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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