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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes, Obesity, Abdominal

Intervention / Treatment
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* Behavioral: Non-exercise control
* Behavioral: Moderate intensity exercise
* Behavioral: Vigorous intensity exercise


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Subjects with NAFLD determined by 1H MRS (intrahepatic triglyceride content ≥5%); 40-65 years old; Waist circumference >90cm for men and >85cm for women Exclusion criteria 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; A history of acute or chronic viral hepatitis, drug-induced liver diseases, and autoimmune hepatitis; Myocardial infarction in the past six months; Biliary obstructive diseases; Uncontrolled hypertension (i.e. systolic BP>180 mmHg, and/or diastolic DBP >100 mmHg); Chronic kidney disease (serum creatinine ≥1.5 mg/dL in men and ≥1.3 mg/dL in women); Heart failure (New York Heart Association III or IV); Currently participating in weight loss programs; Currently pregnant or planning to be pregnant; Having any medical condition that would affect metabolism (i.e. diabetes, known hyperthyroidism or hypothyroidism); 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); Unable to participate in the follow-up examination.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non exercise program<br>Subjects receive 12 month lifestyle education alone. | Behavioral: Non-exercise control<br>* 12 month lifestyle education<br>|
| Moderate intensity exercise program<br>Subjects receive 12 month moderate exercise. | Behavioral: Moderate intensity exercise<br>* 12 month moderate intensity exercise by brisk walk 30 min per day and more than 5 days per week.<br>|
| Vigorous intensity exercise program<br>Subjects receive 6 month vigorous exercise and subsequent 6 month moderate exercise | Behavioral: Vigorous intensity exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of type 2 diabetes | The occurrence of diabetes at 2- and 10-year follow-up | 10 years since randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight change | Body weight change at 2 and 10 year follow-up | 10 years since randomization | 
| Blood pressure change | Systolic and diastolic blood pressure at 2- and 10-year follow-up | 10 years since randomization | 
| Serum lipid change | Serum triglyceride, LDL-c levels at 2- and 10- year follow-up | 10 years since randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Obesity