Obesity and Semaglutide in Type 1 Diabetes Therapy (OBES1TY): A Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial

Condition studied

Obesity defined by BMI equal to or higher than 30, Obesity defined by BMI equal to or higher than 27 and obesity-related diagnosis registered in the electronic patient journal such as: hypertension, hypercholesterolemia, dyslipidemia, micro albuminuria, ischemic heart disease, stroke, atherosclerosis or athrosis), Type 1 Diabetes

Investigational medicinal product(s)

Eligibility

Primary endpoint

Body weight / BMI

Endpoint detail

Blood pressure, Resting heart rate, Waist circumference, hip-waist ratio, Blood samples - hematology (hemoglobin, leucocytes, thrombocytes), Blood samples - glycemic control (HbA1c, fasting plasma-glucose, fasting c-peptide, ketones), Blood samples - lipids (total, HDL, non-HDL, LDL and VLDL cholesterol, triglycerides), Blood samples - kidney (Sodium, Potassium, creatinine/eGFR, Albumin), Blood samples - liver and gut markers (alanine and aspartate transaminase, fibrosis-4-score, amylase, lipase), Blood samples - inflammatory (high sensitivity C-reactive protein), CGM data - Time in/above/below range (TIR, TAR, TBR), time in tight range (TITR) and coefficient of variation (CV), Total daily dose (TDD) of insulin - selfreported, Insulin sensitivity - measures through golden standard hyperinsulinemic euglycemic clamping (for a subgroup consisting of first 40 patients from two specified sites), Fat percentage - measured through DXA scans (for a subgroup consisting of first 40 patients from two specified sites), Lean mass - measured through DXA scans (for a subgroup consisting of first 40 patients from two specified sites), Bone density (through bone mineral content) - measured through DXA scans (for a subgroup consisting of first 40 patients from two specified sites), Blood samples - Omics and metabolomic profile (lipidome and proteome), Transcriptome - through muscle and fat tissue biopsies, Electrocardiogram (ECG), Dietary patterns - through questionnaire, Diabetes treatment satisfaction - through questionnaire, Diabetes distress - through questionnaire