RecruitingNot ApplicableNCT07398300

Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion

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


Sponsor

Rigshospitalet, Denmark

Enrollment

36 participants

Start Date

Mar 12, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 23 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is using a full-body PET scan (a type of medical imaging that shows metabolic activity throughout the body) to look at how two gut hormones — GIP and GLP-1, which are involved in blood sugar control — affect how the body uses glucose (sugar) and how blood flows to different organs. This research may help scientists better understand type 2 diabetes and how drugs like Ozempic work. **You may be eligible if...** - You are between 23 and 64 years old (exact range depends on which sub-study you join) - You are either a healthy adult with a normal BMI and blood sugar, OR you have been diagnosed with type 2 diabetes managed with metformin only - You are able to give informed consent **You may NOT be eligible if...** - You have significant heart, liver, kidney, or thyroid disease - You smoke or use tobacco products - You are pregnant or breastfeeding - You have claustrophobia or cannot tolerate PET scanning procedures - You have a BMI outside the specified range for your sub-study Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGIP

Intravenous infusion of glucose-dependent insulinotropic polypeptide (GIP) consisting of a priming dose of 18 pmol/kg/min for 10 minutes followed by a steady-state infusion of 6 pmol/kg/min during a hyperglycemic clamp. Used to stimulate endogenous insulin secretion and mimic postprandial physiology

DRUGGLP-1

Intravenous infusion of glucagon-like peptide-1 (GLP-1) consisting of a priming dose of 4.5 pmol/kg/min for 10 minutes followed by a steady-state infusion of 1.5 pmol/kg/min during a hyperglycemic clamp. Used to stimulate endogenous insulin secretion and mimic postprandial physiology.

OTHERSaline (0.9% Sodium Chloride)

Intravenous infusion of isotonic saline administered as placebo. In sub-study 1, saline serves as a control condition; in sub-study 2, saline is infused for 15 minutes prior to hormone infusion.


Locations(1)

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark

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NCT07398300


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