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

Fudan University

Status: Completed

Conditions: Obesity, Abdominal; Type 2 Diabetes

Treatments: Behavioral: Vigorous intensity exercise; Behavioral: Non-exercise control; Behavioral: Moderate intensity exercise

Study type: Observational

Funder types: Other

Identifiers

NCT05346250

CCEMD011V2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

220 participants in 3 patient groups

Non exercise program

Description:

Subjects receive 12 month lifestyle education alone.

Treatment:

Behavioral: Non-exercise control

Moderate intensity exercise program

Description:

Subjects receive 12 month moderate exercise.

Treatment:

Behavioral: Moderate intensity exercise

Vigorous intensity exercise program

Description:

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

Treatment:

Behavioral: Vigorous intensity exercise