Intermittent fasting in subjects with insulin-treated type 2 diabetes mellitus
- Conditions
- E11Type 2 diabetes mellitus
- Registration Number
- DRKS00018070
- Lead Sponsor
- Medizinische Universität Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 46
Type 2 Diabetes Mellitus, Age between 18 and 75 years, both inclusive, Glycated hemoglobin levels (HbA1c =7.5%) (Point of care measurements or HbA1c measurement within the last 4 weeks are acceptable), Total daily insulin dose = 0.3 IU/Kg, Stable body weight for preceding 3 months (< 3kg increase or decrease), Able and willing to safely comply with study procedures, Be able to attend the study site and willing to participate in necessary protocols, Be willing to undertake the durations of fasting required by the study
Known malignancy, Pregnancy or intention of becoming pregnant; breastfeeding, History of any chronic disease process that could interfere with interpretation of study results, New hormonal supplementation or new contraceptive hormonal medication for less than 2 months, Type 1 Diabetes Mellitus or other forms of diabetes mellitus, Acute or chronic inflammatory disorder, Alcohol abuse (more than 15 drinks / week), Currently perform overnight shift work, Intake of illicit substances
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in the change of HbA1c from baseline to 12 weeks.<br><br>Co-primary outcome (Difference between intermittent fasting group and control group): Difference in baseline versus 12 weeks post-intervention in number of reaching treat-to-targets assessed by means of a body weight reduction of at least 2 %, an insulin dose reduction of at least 10% and an absolute HbA1c reduction of at least 0.3%.
- Secondary Outcome Measures
Name Time Method