E11
Conditions
Interventions
Group 1: intermittent fasting 3 times a week
Group 2: usual diabetes care
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in the change of HbA1c from baseline to 12 weeks. 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
| Measure | Time frame |
|---|---|
| Differences in the change in resting metabolic rate from baseline to 12 weeks Differences in the change of glucose (Area under the curve) within oGTT from baseline to 12 weeks Differences in the change in glycemic pattern (CGM) from baseline to 12 weeks Differences in the change in body weight and body composition from baseline to 12 weeks Differences in the change in body composition (fat mass/lean body mass) from baseline to 12 weeks Differences in the change in mean 24h blood pressure from baseline to 12 weeks Differences in the change in microbiome composition from baseline to 12 weeks Locate the metabolic changes (metabolomics) of intermittent fasting in type 2 diabetes mellitus from baseline to 12 weeks Differences in the change in insulin dose from baseline to 4 weeks Differences in the change in insulin dose from baseline to 8 weeks Differences in the change in insulin dose from baseline to 12 weeks Differences in the change on quality of life from baseline to 12 weeks Differences in the changes in the sleep quality and sleep disturbances from baseline to 12 weeks Differences in the changes in the sleepiness from baseline to 12 weeks Differences in the changes in physical activity from baseline to 12 weeks Time spent in hypoglycemia, hyperglycemia and number of hypoglycemic events with symptoms and blood glucose <54 mg/dL | — |
Countries
Austria
Contacts
Public ContactNorbert Tripolt
Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz
Outcome results
None listed