Type 2 Diabetes (T2D) Clinical Trials

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Dynamic Whole-Body FDG and H₂¹⁵O PET-CT to Assess Insulin-Mediated Glucose Uptake and Organ Perfusion During GIP and GLP-1 Infusion in Healthy Individuals and Patients With Type 2 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study investigates how the naturally occurring gut hormones GIP and GLP-1 influence whole-body glucose uptake and organ perfusion in humans. Using a state-of-the-art total-body PET-CT scanner, the study measures dynamic uptake of the glucose analogue 18F-FDG and blood flow using H₂¹⁵O across multiple organs during controlled elevations of plasma glucose and endogenous insulin secretion. The project consists of two sub-studies. Sub-study 1 includes healthy individuals who undergo three experimental visits with infusions of GIP, GLP-1, or saline (placebo) during a hyperglycemic clamp followed by FDG PET-CT scanning. Sub-study 2 includes healthy individuals and participants with type 2 diabetes who undergo two experimental visits with saline followed by either GIP or GLP-1 during a hyperglycemic clamp, combined with repeated H₂¹⁵O PET-CT measurements of perfusion. The primary aims are to quantify insulin-mediated skeletal muscle glucose uptake (sub-study 1) and skeletal muscle perfusion (sub-study 2). Secondary aims include assessment of glucose uptake and perfusion across adipose tissue, liver, and additional organs. The results will provide novel physiological insight into postprandial glucose metabolism and serve as reference data for future whole-body PET research.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 23
Maximum Age: 64
Healthy Volunteers: t
View:

⁃ Sub-study 1 (Healthy individuals):

• Age 23-50 years

• BMI 20.0-26.9 kg/m²

• HbA1c \< 42 mmol/mol

• Able to provide informed consent

⁃ Sub-study 2 - Participants with Type 2 Diabetes:

• Age 23-60 years

• Diagnosed with type 2 diabetes for ≥3 months

• HbA1c \> 53 mmol/mol

• Treatment with metformin only

• Able to provide informed consent

⁃ Sub-study 2 - Healthy control participants:

• Age 23-64 years

• HbA1c \< 42 mmol/mol

• Able to provide informed consent

Locations
Other Locations
Denmark
Copenhagen University Hospital - Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Mathilde Borring Brogaard, Doctor
mathilde.borring.brogaard@regionh.dk
+4535454498
Backup
Per Cramon, Doctor
Per.Cramon@regionh.dk
Time Frame
Start Date: 2026-03-12
Estimated Completion Date: 2027-05
Participants
Target number of participants: 36
Treatments
Experimental: GIP infusion
Experimental: GLP-1 infusion
Experimental: Saline Placebo
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov