How the gut hormones GIP and GLP-1 change whole‑body glucose use and organ blood flow
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
We will see if infusions of the gut hormones GIP or GLP‑1 change whole‑body glucose uptake and organ blood flow in healthy people and in people with type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 23 Years to 64 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT07398300 on ClinicalTrials.gov |
What this trial studies
This is a mechanistic imaging study using a total‑body PET‑CT scanner to measure dynamic uptake of the glucose analogue 18F‑FDG and blood flow with H2¹⁵O during controlled hyperglycemia and raised endogenous insulin. The project has two sub‑studies: one where healthy volunteers receive separate infusions of GIP, GLP‑1, or saline during a hyperglycemic clamp with FDG PET‑CT to quantify skeletal muscle glucose uptake, and a second including healthy controls and people with type 2 diabetes who receive saline and either GIP or GLP‑1 with repeated H2¹⁵O PET‑CT to measure organ perfusion. Each participant attends multiple experimental visits with hormone or placebo infusions and PET imaging to compare effects across organs. Results will quantify hormone‑specific effects on tissue glucose handling and blood flow.
Who should consider this trial
Good fit: Eligible participants include healthy adults (broadly aged mid‑20s to mid‑60s with normal HbA1c) and adults with type 2 diabetes aged 23–60 who have had diabetes ≥3 months, are treated only with metformin, and meet the study HbA1c criteria, depending on the sub‑study.
Not a fit: People with significant liver or kidney disease, anemia, prior major abdominal surgery (or certain gastrointestinal conditions), or on glucose‑lowering drugs beyond metformin are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, the findings could reveal hormone mechanisms that improve glucose disposal and organ perfusion and guide development of better treatments for people with type 2 diabetes.
How similar studies have performed: GLP‑1's effects on glucose metabolism are well documented while GIP is less clearly understood, and applying total‑body PET to quantify organ‑level glucose uptake and perfusion is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen
- Copenhagen University Hospital - Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Mathilde Borring Brogaard, Doctor
- Email: mathilde.borring.brogaard@regionh.dk
- Phone: +4535454498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.