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

NCT05346250 | Completed DMC

• 1 other identifier: CCEMD011V2
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes; Obesity, Abdominal

Keywords

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of type 2 diabetes

  The occurrence of diabetes at 2- and 10-year follow-up

  10 years since randomization

Secondary Outcomes (3)

• Body weight change

  10 years since randomization

• Blood pressure change

  10 years since randomization

• Serum lipid change

  10 years since randomization

Study Arms (3)

Non exercise program

Subjects receive 12 month lifestyle education alone.

Behavioral: Non-exercise control

Moderate intensity exercise program

Subjects receive 12 month moderate exercise.

Behavioral: Moderate intensity exercise

Vigorous intensity exercise program

Subjects receive 6 month vigorous exercise and subsequent 6 month moderate exercise

Behavioral: Vigorous intensity exercise

Interventions

Non-exercise control BEHAVIORAL

12 month lifestyle education

Non exercise program

Moderate intensity exercise BEHAVIORAL

12 month moderate intensity exercise by brisk walk 30 min per day and more than 5 days per week.

Moderate intensity exercise program

Vigorous intensity exercise BEHAVIORAL

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.

Vigorous intensity exercise program

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects with NAFLD determined by 1H MRS (intrahepatic triglyceride content ≥5%);
• years old;
• Waist circumference \>90cm for men and \>85cm for women

You may not qualify if:

• 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;
• A history of acute or chronic viral hepatitis, drug-induced liver diseases, and autoimmune hepatitis;
• Myocardial infarction in the past six months;
• Biliary obstructive diseases;
• Uncontrolled hypertension (i.e. systolic BP\>180 mmHg, and/or diastolic DBP \>100 mmHg);
• Chronic kidney disease (serum creatinine ≥1.5 mg/dL in men and ≥1.3 mg/dL in women);
• Heart failure (New York Heart Association III or IV);
• Currently participating in weight loss programs;
• Currently pregnant or planning to be pregnant;
• Having any medical condition that would affect metabolism (i.e. diabetes, known hyperthyroidism or hypothyroidism);
• 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);
• Unable to participate in the follow-up examination.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Related Publications (4)

• Zhang HJ, He J, Pan LL, Ma ZM, Han CK, Chen CS, Chen Z, Han HW, Chen S, Sun Q, Zhang JF, Li ZB, Yang SY, Li XJ, Li XY. Effects of Moderate and Vigorous Exercise on Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. JAMA Intern Med. 2016 Aug 1;176(8):1074-82. doi: 10.1001/jamainternmed.2016.3202.

  PMID: 27379904 RESULT

• Zhang HJ, Pan LL, Ma ZM, Chen Z, Huang ZF, Sun Q, Lu Y, Han CK, Lin MZ, Li XJ, Yang SY, Li XY. Long-term effect of exercise on improving fatty liver and cardiovascular risk factors in obese adults: A 1-year follow-up study. Diabetes Obes Metab. 2017 Feb;19(2):284-289. doi: 10.1111/dom.12809. Epub 2016 Nov 22.

  PMID: 27761987 RESULT

• Zhang HJ, Zhang XF, Ma ZM, Pan LL, Chen Z, Han HW, Han CK, Zhuang XJ, Lu Y, Li XJ, Yang SY, Li XY. Irisin is inversely associated with intrahepatic triglyceride contents in obese adults. J Hepatol. 2013 Sep;59(3):557-62. doi: 10.1016/j.jhep.2013.04.030. Epub 2013 May 9.

  PMID: 23665283 RESULT

• Chen Y, Chen Z, Pan L, Ma ZM, Zhang H, Li XJ, Li X. Effect of Moderate and Vigorous Aerobic Exercise on Incident Diabetes in Adults With Obesity: A 10-Year Follow-up of a Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):272-275. doi: 10.1001/jamainternmed.2022.6291.

  PMID: 36716009 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity, Abdominal; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoying Li, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: July 1, 2011
• Primary Completion: May 15, 2022
• Study Completion: May 30, 2022
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2023-01\~2025-01