Safety and efficacy of intermittent fasting and exercise in overweight people with type 2 diabetes – a randomized controlled trial
- Conditions
- E11Type 2 diabetes mellitus
- Registration Number
- DRKS00032036
- Lead Sponsor
- Medizinische Universität Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
(1) Age between 18 and 75 years, both inclusive
(2) Informed consent has to be given in written form
(3) Body Mass Index >27.0 kg/m2
(4) Glycated haemoglobin levels HbA1c =7.0% (=53mmol/mol) and =10.0% (=86mmol/mol); Point of care measurements or HbA1c measurement within the last 4 weeks are acceptable
(5) Stable body weight for preceding 3 months (< 3kg increase or decrease)
(6) Able and willing to safely comply with study procedures
(7) Be able to attend the study site and willing to participate in necessary protocols
(8) Be willing to undertake the durations of fasting required by the study
(1) Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
(2) Continuous treatment with insulin
(3) Therapy with sulfonylurea
(4) Active known malignancy within the last year excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma
(5) Pregnancy or intention of becoming pregnant; breastfeeding
(6) History of any chronic disease process that could interfere with interpretation of study results
(7) New hormonal supplementation or contraceptive hormonal medication for less than 2 months
(8) Acute or chronic inflammatory disorder
(9) Alcohol abuse (more than 15 drinks / week)
(10) Currently perform overnight shift work
(11) Intake of illicit substances
(12) Subjects with previous or present history of eating disorders
(13) Subject has participated in another study of an investigational medication or an investigational medical device within the last 30 days or is currently participating in these studies
(14) Clinically significant abnormal ECG at screening, as judged by the Investigator
(15) Conditions that prevent people from following the exercise programme
(16) Acute coronary syndrome or stroke within the last 6 months
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Change in body weight from baseline to day 84 between the groups
- Secondary Outcome Measures
Name Time Method