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RECRUITING
NCT05501483
NA

Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

Summary

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.

Official title: Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes: A Randomized Open Intervention Study That Compares Empagliflozin, Pioglitazone and Semaglutide

Key Details

Gender

All

Age Range

30 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-02-08

Completion Date

2032-12-31

Last Updated

2025-02-26

Healthy Volunteers

No

Conditions

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

Locations (1)

Karolinska University Hospital

Stockholm, Sweden