Type 2 Diabetes, Obesity, Abdominal
Conditions
Keywords
Type 2 Diabetes, Obesity
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.
Interventions
BEHAVIORALNon-exercise control
12 month lifestyle education
BEHAVIORALModerate intensity exercise
12 month moderate intensity exercise by brisk walk 30 min per day and more than 5 days per week.
BEHAVIORALVigorous 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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of type 2 diabetes | 10 years since randomization | The occurrence of diabetes at 2- and 10-year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight change | 10 years since randomization | Body weight change at 2 and 10 year follow-up |
| Blood pressure change | 10 years since randomization | Systolic and diastolic blood pressure at 2- and 10-year follow-up |
| Serum lipid change | 10 years since randomization | Serum triglyceride, LDL-c levels at 2- and 10- year follow-up |
Outcome results
None listed