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

NCT07398300 | Recruiting DMC

• 1 other identifier: H-25055805
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healhty; Type 2 Diabetes

Keywords

IncretinPET

Outcome Measures

Primary Outcomes (1)

• Metabolic Rate of FDG

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

  75 minuts

Secondary Outcomes (1)

• Perfusion of skeletal muscle

  75 min

Study Arms (3)

GIP infusion

EXPERIMENTAL

Drug: GIP

GLP-1 infusion

EXPERIMENTAL

Drug: GLP-1

Saline Placebo

EXPERIMENTAL

Other: Saline (0.9% Sodium Chloride)

Interventions

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

GIP infusion

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.

GLP-1 infusion

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.

Saline Placebo

Eligibility Criteria

• Age: 23 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Copenhagen University Hospital - Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucagon-Like Peptide 1; Sodium Chloride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Mathilde Borring Brogaard, Doctor

CONTACT

+4535454498; mathilde.borring.brogaard@regionh.dk

Per Cramon, Doctor

CONTACT

Per.Cramon@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Two randomized crossover studies: Sub-study 1 uses a 3-period crossover (GIP, GLP-1, placebo) in healthy individuals; Sub-study 2 uses a 2-period crossover (GIP, GLP-1) in healthy individuals and participants with type 2 diabetes.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 9, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): March 12, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)