E11 E66
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Cohort I (Cohort with healthy, non-obese subjects) - Age >18 years - Body mass index in the range of 20.0 – 27.0 kg/m2 - Fasting plasma glucose 18 years - Body mass index > 30.0 kg/m2 - Fasting plasma glucose 18 years - established diabetes mellitus type 2 on either diet or a monotherapy or combination of metformin, DPP-4-inhibitors or sulfonylurea Inclusion Criteria Cohort IV (Cohort with Subjects with Type 1 Diabetes) - Age > 18 years - Diagnosed with type 1 diabetes > 12 months - Treated with multiple daily insulin injections (MDII) or continuous subcutaneous insulin infusion (CSII) - Stable insulin therapy as clinically assessed by the study physician - C-peptide negative defined as 0.3 nmol/L - HbA1c < 9.5% - No diabetic ketoacidosis within the last 12 months - No severe hypoglycaemia requiring external assistance within the last 12 months - Running on the FreeStyle Libre 1 (Abbott, USA) intermittently-viewed continuous glucose monitoring system (iCGM) as standard of care for glucose monitoring
Exclusion criteria
Exclusion criteria: Exclusion criteria cohort I - Presence of any metabolic disease - Intake of any glucose lowering, lipid lowering or blood pressure lowering medication Exclusion criteria cohort II - Intake of any glucose lowering medication Exclusion Criteria (for all participants) - history of cardiovascular disease - acute or chronic inflammatory disorder - heavy drinking (more than 15 drinks/week) dietary restrictions (e.g. vegetarianism and vegan) - Insulin treatment (excluded subjects with type 1 diabetes) - Corticosteroid therapy - Known Malignancy - Women who are pregnant, breast-feeding or trying to become pregnant - History of any chronic disease process that could interfere with interpretation of study results - Therapy with antidepressants within past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in 2-hour glucose in an oral glucose tolerance test after 12 and 36 hours of fasting | — |
Secondary
| Measure | Time frame |
|---|---|
| - Differences in insulin sensitivity (Matsuda Index, ISI, HOMA-Index, QUICKI) after 12 and 36 hours of fasting - Differences in glycaemic pattern (AUC in OGTT) after 12 and 36 hours of fasting - Differences in body composition after 12 and 36 hours of fasting | — |
Countries
Austria
Contacts
Medizinische Universität Graz