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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05346250
Other study ID # CCEMD011V2
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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