Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pioglitazone 45 mg, Empagliflozin 25 MG, Semaglutide 7 MG.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 30 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes: A Randomized Open Intervention Study That Compares Empagliflozin, Pioglitazone and Semaglutide
Overview
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.
Interventions
- 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
Primary outcome measures
- Changes in fat cell lipolysis after 6 months of treatment [Time frame: Baseline and after six months intervention]
Secondary outcome measures (1)
- Changes in fat cell heterogeneity after 6 months of treatment [Time frame: Baseline and after six months intervention]
Eligibility criteria
Inclusion criteria
- Signed informed consent
- BMI 25 kg/m2 or higher
- HbA1c 42 mmol/mol or higher
- For fertile women, effective contraception
Exclusion criteria
- HbA1c 65 mmol/mol or higher
- Established cardiovascular disease and/or heart failure
- Severe psychiatric condition
- Active alcoholism
- Insulin treatment
- Anticoagulant therapy (vitamin K antagonists or equivalent)
- Pregnancy, lactation
- Positive GAD or IA2 antibodies
- Low C-peptide/glucose ratio (less than 2 measured as pmol/mg per dL)
- NT-proBNP above the upper normal reference value
- Kidney disease
- Liver disease or hepatic values over twice the upper reference value
- Severe concomitant disease including ongoing cancer
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Karolinska University Hospital — Stockholm
Identifiers
NCT: NCT05501483 · Karolinska University Hospital · 2022-00792 and 2024-03434 · 2021-002367-21