Karolinska University Hospital
Stockholm, 14186, Sweden
Location status: Recruiting
Location contact
Daniel P Andersson, MD, PhD
SUB_INVESTIGATOR
Jesper Bäckdahl, MD, PhD
CONTACT
Mikael Rydén, MD, PhD
CONTACT
Niklas Mejhert, PhD
SUB_INVESTIGATOR
Recruiting
NCT Number: NCT05501483
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
30 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Pioglitazone 45 mg
DrugStarts with 45 mg
Empagliflozin 25 MG
DrugStarts with 25 mg
Semaglutide 7 mg
DrugStarts with 3 mg daily for the first 2 weeks
Primary outcomes
-
Changes in fat cell lipolysis after 6 months of treatment
Time frame: Baseline and after six months intervention
Change in isoprenaline-induced (over basal) lipolysis in isolated fat cells
Secondary outcomes
-
Changes in fat cell heterogeneity after 6 months of treatment
Time frame: Baseline and after six months intervention
Changes in the adiponectin/leptin mRNA expression ratio in adipose tissue measured by quantitative PCR
Other outcomes
-
Changes in tissue cellularity after 6 months of treatment (explorative outcome)
Time frame: Baseline and after six months intervention
Changes in adipose tissue cellularity measured by single-cell transcriptomic analyses of fat tissue biopsies
Study contacts
Contact information is provided by the study sponsor or research team.
Jesper Bäckdahl, MD, PhD
CONTACT
Mikael Ryden, MD, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Karolinska Institutet
Other
Collaborators
- Karolinska University Hospital
Registry information
Official study title
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes: A Randomized Open Intervention Study That Compares Empagliflozin, Pioglitazone and Semaglutide
Acronym: DiaSpax
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2032
- First posted
- Aug 15, 2022
- Registry last updated
- Feb 26, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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