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NCT Number: NCT07398300

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

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.

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Key information

Age range

23 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital - Rigshospitalet

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Peter Hovind, Cheif doctor

CONTACT

[email protected]

+4535459824

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

(applies to all participants unless otherwise specified):

  • Anaemia (haemoglobin below normal range)
  • ALT > 2× upper normal limit or any known hepatobiliary or gastrointestinal disorder
  • Kidney disease (creatinine above normal range)
  • Previous gastric or intestinal resection (except appendectomy or cholecystectomy) or major abdominal surgery (including bariatric surgery)
  • For Sub-study 1: Type 1 or type 2 diabetes or HbA1c ≥ 42 mmol/mol
  • Use of glucose-lowering medications other than metformin (Sub-study 2 only)
  • Chronic obstructive pulmonary disease (Sub-study 2 only)
  • Regular tobacco smoking or use of nicotine-containing products
  • Claustrophobia
  • Pregnancy, breastfeeding, or intention to become pregnant during the study period
  • Initiation of special diets, major lifestyle changes, or weight loss > 5% within 3 months prior to or during the study
  • Any medication or physical/psychological condition that may interfere with participation (per investigator judgement)
  • Inability to speak or read Danish

Treatment and study plan

GIP

Drug

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

GLP-1

Drug

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.

Saline (0.9% Sodium Chloride)

Other

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.

Primary outcomes

  1. Metabolic Rate of FDG

    Time frame: 75 minuts

    MRFDG quantified using dynamic total-body 18F-FDG PET with 3-compartment kinetic modelling during infusion of GIP, GLP-1, or placebo.

Secondary outcomes

  1. Perfusion of skeletal muscle

    Time frame: 75 min

Study contacts

Contact information is provided by the study sponsor or research team.

Mathilde Borring Brogaard, Doctor

CONTACT

[email protected]

+4535454498

Per Cramon, Doctor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

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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