Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes
Key facts
- Where
- Aarhus N and Herlev, DenmarkSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 70 years old?
Source: NCT05501483, who can take part
Where in Denmark
- Aarhus University HospitalAarhus N, DenmarkNot yet recruiting
- Steno Diabetes Center CopenhagenHerlev, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karolinska Institutet
- Trial code
- NCT05501483EU 2024-513416-98-00
- Record updated
- 26 February 2025
- Original description
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.Read full original descriptionShow less
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes: A Randomized Open Intervention Study That Compares Empagliflozin, Pioglitazone and Semaglutide
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.
Inclusion: Signed informed consent; BMI 25 kg/m2 or higher; HbA1c 42 mmol/mol or higher; For fertile women, effective contraception.
Exclusion: Anticoagulant therapy (vitamin K antagonists or equivalent); Positive GAD or IA2 antibodies; Severe concomitant disease including ongoing cancer; Established cardiovascular disease and/or heart failure; Severe psychiatric condition; Kidney disease; Liver disease or hepatic values over twice the upper reference value; HbA1c 65 mmol/mol or higher; Low C-peptide/glucose ratio (less than 2 measured as pmol/mg per dL); Active alcoholism; Insulin treatment; Pregnancy, lactation; NT-proBNP above the upper normal reference value.