Type 2 DiabetesNCT07398300
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion
A study testing GIP, GLP-1 and Saline (0.9% Sodium Chloride) in people with Type 2 Diabetes and Healhty, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 23 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Healhty
- What is being tested?
- GIP, GLP-1 and Saline (0.9% Sodium Chloride)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Mar 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Per Cramon, Doctor contact
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100
Peter Hovind, Cheif doctor, +4535459824, peter.hovind@regionh.dk
About this study
Official 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
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.
Read more
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
- Type 2 Diabetes, Healhty
- Being tested
- GIP, GLP-1, Saline (0.9% Sodium Chloride)
- Keywords
- IncretinPET
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIPDrug
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-1Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| GIP infusion | Experimental | Not described Receives: Drug: GIP |
| GLP-1 infusion | Experimental | Not described Receives: Drug: GLP-1 |
| Saline Placebo | Experimental | Not described Receives: Other: Saline (0.9% Sodium Chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 75 minuts
Secondary outcomes (1)
Perfusion of skeletal muscle
Measured: 75 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start12 Mar 2026
- Primary completion12 Mar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathilde Borring Brogaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398300
- Sponsor's protocol ID
- H-25055805
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07398300
- Acronym / sponsor ID
- H-25055805
- Conditions
- Type 2 Diabetes, Healhty
- Keywords
- IncretinPET
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 12 Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GIP infusion | Experimental | Drug: GIP |
| GLP-1 infusion | Experimental | Drug: GLP-1 |
| Saline Placebo | Experimental | Other: Saline (0.9% Sodium Chloride) |
Who may qualify
- Ages
- 23 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIPIntravenous 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 | Drug | GIP infusion |
| GLP-1Intravenous 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. | Drug | GLP-1 infusion |
| 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. | Other | Saline Placebo |
Primary outcome
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.
1 secondary outcome
Perfusion of skeletal muscle
Time frame: 75 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Per Cramon, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIP, GLP-1 and Saline (0.9% Sodium Chloride) in people with Type 2 Diabetes and Healhty, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Borring Brogaard, Doctor (+4535454498, mathilde.borring.brogaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Rate of FDG (time frame: 75 minuts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.