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

NCT ID: NCT05346250

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-01
• Study Completion Date: 2022-05-30

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.

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.

Conditions

Type 2 Diabetes; Obesity, Abdominal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non exercise program

Subjects receive 12 month lifestyle education alone.

Non-exercise control

Intervention Type: BEHAVIORAL

12 month lifestyle education

Moderate intensity exercise program

Subjects receive 12 month moderate exercise.

Moderate intensity exercise

Intervention Type: BEHAVIORAL

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

Vigorous intensity exercise

Intervention Type: 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.

Interventions

Non-exercise control

12 month lifestyle education

Intervention Type: BEHAVIORAL

Moderate intensity exercise

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaoying Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoying Li, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

References

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.

Reference Type: RESULT

PMID: 27379904 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27761987 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23665283 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36716009 (View on PubMed)

Other Identifiers

CCEMD011V2

Identifier Type: -

Identifier Source: org_study_id