Actively Recruiting
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes
Led by Karolinska Institutet · Updated on 2025-02-26
60
Participants Needed
1
Research Sites
516 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Body mass index (BMI) of 25 kg/m2 or higher
- HbA1c level of 42 mmol/mol or higher
- Effective contraception for women who can become pregnant
You will not qualify if you...
- HbA1c level of 65 mmol/mol or higher
- Established cardiovascular disease or heart failure
- Severe psychiatric condition
- Active alcoholism
- Treatment with insulin
- Use of anticoagulant therapy (vitamin K antagonists or equivalent)
- Pregnancy or breastfeeding
- Positive for GAD or IA2 antibodies
- Low C-peptide/glucose ratio (less than 2 pmol/mg per dL)
- NT-proBNP above normal reference value
- Kidney disease
- Liver disease or liver test values more than twice the upper normal limit
- Severe other diseases including ongoing cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
Karolinska University Hospital
Stockholm, Sweden, 14186
Actively Recruiting
Research Team
M
Mikael Ryden, MD, PhD
CONTACT
J
Jesper Bäckdahl, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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