Investigating how different diabetes medications affect fat tissue in type 2 diabetes patients
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes: A Randomized Open Intervention Study That Compares Empagliflozin, Pioglitazone and Semaglutide
This study is testing how three different diabetes medications affect fat tissue in people with newly diagnosed type 2 diabetes who aren't meeting their blood sugar goals on metformin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05501483 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI of 25 kg/m2 or higher and an HbA1c level between 42-64 mmol/mol who are newly diagnosed with type 2 diabetes.
Not a fit: Patients with severe comorbidities, established cardiovascular disease, or those on insulin treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results in understanding the relationship between adipose tissue and diabetes treatment, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Mikael Ryden, MD, PhD
- Email: mikael.ryden@ki.se
- Phone: +46736995215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.