NCT05501483

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A detailed description of the protocol has been approved by the Swedish Medical Products Agency and the study is registered as EudraCT: 2021-002367-21.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-08
• Primary completion: 2026-09-01
• Completion: 2032-12-31
• First posted: 2022-08-15
• Last updated: 2025-02-26

Locations

1 site across 1 country: Sweden