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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Starts with 45 mg
Starts with 25 mg
Starts with 3 mg daily for the first 2 weeks
Karolinska University Hospital
Stockholm, Sweden
RECRUITINGChanges in fat cell lipolysis after 6 months of treatment
Change in isoprenaline-induced (over basal) lipolysis in isolated fat cells
Time frame: Baseline and after six months intervention
Changes in fat cell heterogeneity after 6 months of treatment
Changes in the adiponectin/leptin mRNA expression ratio in adipose tissue measured by quantitative PCR
Time frame: Baseline and after six months intervention
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