drugset / Trial / NCT05501483

Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes

NCT05501483

RandomizedParallel-groupOpen-labelTreatment

Summary

People with newly diagnosed type 2 diabetes treated with metformin that have not reached their HbA1c target (42-64 mmol/mol) will be recruited to the study. If they fulfill the inclusion and none of the exclusion criteria, they will be, after signing informed consent, randomized to a six-month intervention with either pioglitazone, empagliflozin or semaglutide. Fat biopsies are obtained from the subcutaneous abdominal area before and after a hyperinsulinemic-euglycemic clamp at baseline and after six months. Participants are regularly followed during this the intervention. The overall goal is to determine how antidiabetic-drugs affect white adipose tissue cellularity and whether adipose heterogeneity impacts on drug response. The primary outcome measure is the change in fat tissue lipolysis (glycerol release in isolated fat cells after hormone stimulation) before and after treatment.

Timeline

Start
2023-02-08
Primary completion
2026-09-01
Completion
2032-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 25 mg
Comparator Pioglitazone Small molecule 45 mg
Subject Semaglutide Peptide 7 mg