Clinical trial

Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes

Recruiting now · Not applicable · 1 countries · Registry ID NCT05501483

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes

Full registry 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

Treatments and study arms

Pioglitazone 45 mg

Drug

Starts with 45 mg

Empagliflozin 25 MG

Drug

Starts with 25 mg

Semaglutide 7 MG

Drug

Starts with 3 mg daily for the first 2 weeks

Primary outcomes

Changes in fat cell lipolysis after 6 months of treatmentBaseline and after six months intervention

Change in isoprenaline-induced (over basal) lipolysis in isolated fat cells

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Karolinska University Hospital🇸🇪 Stockholm, Sweden

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Mikael Rydén, MD, PhDContact

Email · Call 0736995215

Jesper Bäckdahl, MD, PhDContact

Email · Call +46702297237

Niklas Mejhert, PhDSub Investigator