RecruitingNot ApplicableNCT05501483

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

Sponsor

Karolinska Institutet

Enrollment

60 participants

Start Date

Feb 8, 2023

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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.

Eligibility

Min Age: 30 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how fat tissue in different parts of the body differs in people with pre-diabetes or early type 2 diabetes. Researchers will take small fat samples to look at how the cells function and how that connects to blood sugar problems. **You may be eligible if...** - Your BMI is 25 or above - Your HbA1c (a blood sugar marker) is mildly elevated (42 mmol/mol or above), suggesting pre-diabetes or early diabetes - Women of childbearing age must use effective contraception **You may NOT be eligible if...** - Your HbA1c is very high (65 mmol/mol or above, suggesting well-established diabetes) - You have heart disease, heart failure, kidney or liver disease - You are on insulin or blood thinners - You have a severe psychiatric condition, active alcoholism, or cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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