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Clinical Trial NCT07398300 for Type 2 Diabetes, Healhty is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion 36 Novel Treatment
The project consists of ...
Show MoreDynamic 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
- H-25055805
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalGIP infusion | GIP 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 |
ExperimentalGLP-1 infusion | GLP-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. |
ExperimentalSaline Placebo | Saline (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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Perfusion of skeletal muscle | 75 min |
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
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
Rigshospitalet, Denmark