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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346250
• Other study ID #: CCEMD011V2
• Status: Completed
• Start date: July 1, 2011
• Est. completion date: May 30, 2022

Study information

• Verified date: June 2023
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: May 30, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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. ß-blockers);

12. Unable to participate in the follow-up examination.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity, Abdominal
• Type 2 Diabetes

Intervention

Behavioral:
• Non-exercise control
12 month lifestyle education
• 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

References & Publications (3)

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; — View Citation

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;1 — View Citation

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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of type 2 diabetes	The occurrence of diabetes at 2- and 10-year follow-up	10 years since randomization
Secondary	Body weight change	Body weight change at 2 and 10 year follow-up	10 years since randomization
Secondary	Blood pressure change	Systolic and diastolic blood pressure at 2- and 10-year follow-up	10 years since randomization
Secondary	Serum lipid change	Serum triglyceride, LDL-c levels at 2- and 10- year follow-up	10 years since randomization