Investigating how different diabetes medications affect fat tissue in type 2 diabetes patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study recruits individuals with newly diagnosed type 2 diabetes who are not achieving their blood sugar targets on metformin. Participants will be randomized to receive one of three medications—pioglitazone, empagliflozin, or semaglutide—over a six-month period. Fat biopsies will be taken before and after treatment to assess changes in fat tissue cellularity and lipolysis. The goal is to understand how these medications influence adipose tissue and how this may affect their effectiveness in managing diabetes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent
* BMI 25 kg/m2 or higher
* HbA1c 42 mmol/mol or higher
* For fertile women, effective contraception

Exclusion Criteria:

* 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 it's running

• Karolinska University Hospital
  Stockholm, Sweden Recruiting

Study contacts

• Study coordinator: Mikael Ryden, MD, PhD
• Email: mikael.ryden@ki.se
• Phone: +46736995215

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.