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
New PET-CT Scan Explores Hormone Effects on Glucose Uptake in Diabetes
Plain English Summary
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion is a Not Applicable clinical trial sponsored by Rigshospitalet, Denmark studying Type 2 Diabetes, Healhty. This study uses advanced PET-CT imaging to see how gut hormones (GIP and GLP-1) affect how the body uses glucose and blood flow in different organs. It is for healthy individuals and people with Type 2 Diabetes. Participants will receive infusions of hormones or a placebo, and undergo PET-CT scans. This involves multiple visits. Alternatives include standard diabetes management and other diagnostic tests, but this study offers a unique look at real-time bodily processes. The trial aims to enroll 36 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Healthy individuals aged 23-50 with a BMI between 20.0-26.9 and no diabetes (HbA1c < 42 mmol/mol) can join. People with Type 2 Diabetes aged 23-60, diagnosed for at least 3 months, on metformin only, and with HbA1c > 53 mmol/mol can join. You cannot join if you have anemia, significant liver or kidney problems, a history of major stomach surgery, or are pregnant or breastfeeding. Other reasons for exclusion include smoking, claustrophobia, or conditions that might interfere with the study, as decided by the doctor. This trial is studying Type 2 Diabetes, Healhty, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how quickly your muscles take up a special sugar (FDG) after receiving hormones, showing how well your body is using glucose. The specific primary outcome measures are: Metabolic Rate of FDG (75 minuts). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it aims to provide a deeper understanding of how key hormones regulate glucose metabolism and blood flow, which could lead to better treatments for Type 2 Diabetes. This research targets Type 2 Diabetes, Healhty, where improved treatment options are needed.
Investor Insight
This study is exploring novel physiological insights into diabetes metabolism using cutting-edge imaging technology, potentially paving the way for new diagnostic tools and therapeutic targets in a la
Is This Trial Right for Me?
Ask your doctor about the specific procedures, the number of visits required, and what to expect during the PET-CT scans. Participation involves several study visits where you will receive infusions and undergo imaging scans. You will be monitored closely throughout. Be prepared for potential dietary restrictions or changes in medication timing around study visits. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: CROSSOVER
- Masking: NONE
- Enrollment: 36 participants
Interventions
- DRUG: 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
- DRUG: 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.
- OTHER: 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.
Primary Outcomes
- Metabolic Rate of FDG (75 minuts)
Secondary Outcomes
- Perfusion of skeletal muscle (75 min)
Full Eligibility 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
Trial Locations
- Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
Frequently Asked Questions
What is clinical trial NCT07398300?
NCT07398300 is a Not Applicable INTERVENTIONAL study titled "Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion." It is currently recruiting and is sponsored by Rigshospitalet, Denmark. The trial targets enrollment of 36 participants.
What conditions does NCT07398300 study?
This trial investigates treatments for Type 2 Diabetes, Healhty. The primary condition under study is Type 2 Diabetes.
What treatments are being tested in NCT07398300?
The interventions being studied include: GIP (DRUG), GLP-1 (DRUG), Saline (0.9% Sodium Chloride) (OTHER). 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
What does Not Applicable mean for NCT07398300?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07398300?
This trial is currently "Recruiting." It started on 2026-03-12. The estimated completion date is 2027-05.
Who is sponsoring NCT07398300?
NCT07398300 is sponsored by Rigshospitalet, Denmark. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07398300?
The trial aims to enroll 36 participants. The trial is currently recruiting and accepting new participants.
How is NCT07398300 designed?
This is a interventional study, uses randomized allocation, follows a crossover design, employs none masking.
What are the primary outcomes being measured in NCT07398300?
The primary outcome measures are: Metabolic Rate of FDG (75 minuts). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07398300 being conducted?
This trial is being conducted at 1 site, including Copenhagen (Denmark).
Where can I find official information about NCT07398300?
The official record for NCT07398300 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07398300. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07398300 testing in simple terms?
This study uses advanced PET-CT imaging to see how gut hormones (GIP and GLP-1) affect how the body uses glucose and blood flow in different organs. It is for healthy individuals and people with Type 2 Diabetes.
Why is this trial significant?
This trial is important because it aims to provide a deeper understanding of how key hormones regulate glucose metabolism and blood flow, which could lead to better treatments for Type 2 Diabetes.
What are the potential risks of participating in NCT07398300?
Potential side effects from the hormone infusions could include nausea, vomiting, or changes in blood sugar levels. The PET-CT scan involves radiation exposure, though the amount is carefully controlled and considered safe for research purposes. Some participants might experience discomfort at the infusion site or temporary flushing. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07398300?
Ask your doctor about the specific procedures, the number of visits required, and what to expect during the PET-CT scans. Participation involves several study visits where you will receive infusions and undergo imaging scans. You will be monitored closely throughout. Be prepared for potential dietary restrictions or changes in medication timing around study visits. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07398300 signal from an investment perspective?
This study is exploring novel physiological insights into diabetes metabolism using cutting-edge imaging technology, potentially paving the way for new diagnostic tools and therapeutic targets in a la This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive infusions of hormones or a placebo, and undergo PET-CT scans. This involves multiple visits. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.