Recruiting

Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes

ClinicalTrials.gov IDNCT05501483

PhaseNA

Enrollment60

SponsorKarolinska Institutet

Age30 Years – 70 Years

SexALL

I'm interested View official listing

Conditions studied

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.

Interventions

Drug: Pioglitazone 45 mg — Starts with 45 mg
Drug: Empagliflozin 25 MG — Starts with 25 mg
Drug: Semaglutide 7 MG — Starts with 3 mg daily for the first 2 weeks

Primary outcomes

Changes in fat cell lipolysis after 6 months of treatment (Baseline and after six months intervention)

Eligibility information

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

Study locations

Karolinska University Hospital, Stockholm, 14186 Sweden

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-21.