E11
Conditions
Interventions
Group 1: Intermittent fasting group
Participants of the intermittent fasting group will be instructed to consume only 25% of the recommended calorie intake (75% caloric restriction) between noon and
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (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
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Change in body weight from baseline to day 84 between the groups | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change in Time In Range (TIR) [70-180 mg/dL; 3.9-10.0 mmol/L] from baseline up to day 84 (2) Change in the composite of improvement in TIR of at least 5%, weight reduction of at least 3% and stable or reduced glucose lowering treatment at day 84 (3) Differences in TBR1 [54-250 mg/dL; >13.9 mmol/L) from baseline to day 84 (6) Differences in glycaemic variability (%CV, SD) from baseline to day 84 (7) Differences in numbers of hypoglycaemia (15 min as assessed via continuous glucose monitoring (CGM) from baseline to day 84 (8) Differences in the change of glycated haemoglobin (HbA1c) from baseline to day 84 (9) Differences in body composition (body mass, fat mass, lean mass) from baseline to day 28, 56 and day 84 (10) Differences in resting metabolic rate (RMR) from baseline to day 84 (11) Differences in the change of quality of life from baseline to day 84 (12) Differences in the change of calorie intake from baseline to day 84 (13) Differences in the change of physical activity (IPAQ, Movisens) from baseline to day 84 (14) Differences in the change of fasting glucose from baseline to day 84 (15) Differences in the incremental area under the curve (iAUC) for glucose from baseline to day 84 during the oGTT (16) Differences in the incremental area under the curve (iAUC) for insulin from baseline to day 84 during the oGTT (17) Differences in the trapezoidal area under the curve (tAUC) for glucose from baseline to day 84 during the oGTT (18) Differences in the trapezoidal area under the curve (tAUC) for insulin from baseline to day 84 during the oGTT (19) Differences in the peak plasma glucose concentration during OGTT from baseline to day 84 (20) Differences in the change of insulin resistance (HOMA-IR, insulinogenic index) from baseline to day 84 (21) Differences in the change of insulin sensitivity (Matsuda-Index) from baseline to day 84 (22) Differences in sleep quality and duration (PSQI Questionnaire) from baseline to day 84 (23) Differences | — |
Countries
Austria
Contacts
Public ContactHarald Sourij
Medizinische Universität Graz / Abteilung für Endokrinologie und Diabetologie
Outcome results
None listed