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

Phase 2

Recruiting

• Conditions: Diabetes type 2

• Registration Number: 2024-513416-98-00
• Lead Sponsor: Karolinska University Hospital

Brief Summary

How do various antidiabetic drugs differ in their beneficial effects on adipose tissue function?

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-06-11
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

The participant has provided written consent to participate in the study

Age 30-70

BMI ≥25

HbA1c ≥42 mmol/mol

Fertile women must use effective contraception throughout the study. Effective contraception includes any of the following: Combined hormonal contraceptives (estrogen and progestogen) that inhibit ovulation: oral, intravaginal, or transdermal; Progestogen-only contraceptives that inhibit ovulation: oral, injectable, or implantable; Intrauterine device (hormonal or copper); Bilateral tubal occlusion; Vasectomized partner; Sexual abstinence (refraining from heterosexual intercourse throughout the study). Women of childbearing potential need a negative pregnancy test at screening before randomization.

Exclusion Criteria

HbA1C ≥ 65 mmol/mol

Insulin treatment

Waran or NOAK-treatment

Pregnancy, nursing or planned pregnancy

Ongoing pregnancy (positive pregnancy test)

Positive GAD or IA2 antibodies (Above reference range)

Hypersensitivity to the active substance or any of its excipients

History of bladder cancer

Uninvestigated macroscopic hematuria

Low C-peptide/glucose ratio indicative of endogenous insulin deficiency (less than 2 measured as pmol/mg per dL)

NT-proBNP 20% above the normal reference value

Kidney disease/impairment (eGFR <60 ml/min)

Liver disease and/or impairment (hepatic values over twice the upper reference value)

Other severe chronic illness including ongoing cancer

Established cardiovascular disease and/or heart failure

Severe psychiatric condition

Active alcoholism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lipolysis is measured as basal and maximal isoprenaline-stimulated lipolysis in isolated adipocytes from the subcutaneous abdominal periumbilical adipose tissue and expressed as log10 ISO-stimulated/basal glycerol release ex vivo		Lipolysis is measured as basal and maximal isoprenaline-stimulated lipolysis in isolated adipocytes from the subcutaneous abdominal periumbilical adipose tissue and expressed as log10 ISO-stimulated/basal glycerol release ex vivo

Secondary Outcome Measures

Name	Time	Method
The cellular heterogeneity of adipose tissue (i.e., different adipocyte subtypes) is measured using qPCR of ADIPOQ/LEP in the same adipose tissue samples from which lipolysis is measured.		The cellular heterogeneity of adipose tissue (i.e., different adipocyte subtypes) is measured using qPCR of ADIPOQ/LEP in the same adipose tissue samples from which lipolysis is measured.

Trial Locations

Locations (3)

Karolinska University Hospital; 🇸🇪 Huddinge, Sweden

Steno Diabetes Center Copenhagen; 🇩🇰 Herlev, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Karolinska University Hospital

🇸🇪Huddinge, Sweden

Mikael Rydén

Site contact

+46736995215

mikael.ryden@ki.se