Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes
About this study
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.
- Condition
- Type 2 Diabetes
- Tested
- Pioglitazone 45 mg, Empagliflozin 25 MG, Semaglutide 7 MG
- Sponsor
- Karolinska Institutet
Who can join
- Age
- 30 to 70 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 30 years
- Maximum age: 70 years
- Study condition: Type 2 Diabetes
- Signed informed consent
- BMI 25 kg/m2 or higher
- HbA1c 42 mmol/mol or higher
- For fertile women, effective contraception
Exclusion 13
- HbA1c 65 mmol/mol or higher
- Established cardiovascular disease and/or heart failure
- Severe psychiatric condition
- Active alcoholism
- Insulin treatment
- Anticoagulant therapy (vitamin K antagonists or equivalent)
- Pregnancy, lactation
- Positive GAD or IA2 antibodies
- Low C-peptide/glucose ratio (less than 2 measured as pmol/mg per dL)
- NT-proBNP above the upper normal reference value
- Kidney disease
- Liver disease or hepatic values over twice the upper reference value
- Severe concomitant disease including ongoing cancer
Where
1 site, 1 recruiting
Karolinska University Hospital
Stockholm, Sweden
Contact
-
Mikael Ryden, MD, PhD
+46736995215 mikael.ryden@ki.se
-
Jesper Bäckdahl, MD, PhD
+46702297237 jesper.backdahl@ki.se
Potential match only. Final eligibility is determined by the study team.