Clinical trial NCT05346250: Long-term Effect of Moderate and Vigorous Exercise on Incident Diabetes in Obese Subjects
Official title: Effect of Moderate and Vigorous Exercise on Incident Diabetes in Central Obese Subjects: a 10-year Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Obesity, Abdominal
Keywords: Type 2 Diabetes
Obesity
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 220
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Incidence of type 2 diabetes
timeFrame: 10 years since randomization
Secondary outcomes:
measure: Body weight change
timeFrame: 10 years since randomization
measure: Blood pressure change
timeFrame: 10 years since randomization
measure: Serum lipid change
timeFrame: 10 years since randomization
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Xiaoying Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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;19(2):284-289. doi: 10.1111/dom.12809. Epub 2016 Nov 22.
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. Epub 2013 May 9.