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Completed

NCT Number: NCT05346250

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-exercise control

Behavioral

12 month lifestyle education

Moderate Intensity Exercise

Behavioral

12 month moderate intensity exercise by brisk walk 30 min per day and more than 5 days per week.

Vigorous intensity exercise

Behavioral

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.

Primary outcomes

  1. Incidence of type 2 diabetes

    Time frame: 10 years since randomization

    The occurrence of diabetes at 2- and 10-year follow-up

Secondary outcomes

  1. Body weight change

    Time frame: 10 years since randomization

    Body weight change at 2 and 10 year follow-up

  2. Blood pressure change

    Time frame: 10 years since randomization

    Systolic and diastolic blood pressure at 2- and 10-year follow-up

  3. Serum lipid change

    Time frame: 10 years since randomization

    Serum triglyceride, LDL-c levels at 2- and 10- year follow-up

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2022
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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