NCT05501483RecruitingPhase 2
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes: A Randomized Open Intervention Study That Compares Empagliflozin, Pioglitazone and Semaglutide
Source: ClinicalTrials.gov · Last updated 26 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 Aug 2022
- Start date
- 8 Feb 2023
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Karolinska Institutet
- Diseases
- Type 2 diabetes
- NCT number
- NCT05501483
- EU CT number
- 2024-513416-98-00
- EudraCT number
- 2021-002367-21
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 8 Feb 2023 to the primary completion date, 1 Sept 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticoagulant therapy (vitamin K antagonists or equivalent)
- Positive GAD or IA2 antibodies
- Severe concomitant disease including ongoing cancer
Other illness
- Established cardiovascular disease and/or heart failure
- Severe psychiatric condition
- Kidney disease
- Liver disease or hepatic values over twice the upper reference value
Lab values
- HbA1c 65 mmol/mol or higher
- Low C-peptide/glucose ratio (less than 2 measured as pmol/mg per dL)
Other
- Active alcoholism
- Insulin treatment
- Pregnancy, lactation
- NT-proBNP above the upper normal reference value
Who the study is looking for
- Signed informed consent
- BMI 25 kg/m2 or higher
- HbA1c 42 mmol/mol or higher
- For fertile women, effective contraception
Age in the registry: 30 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Not yet recruiting |
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Herlev | Denmark | Not yet recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.