Clinical trial

Total-body Glucose Utilization in Obesity

Recruiting now · Phase 4 · 1 countries · Registry ID NCT06739473

Recruiting nowPhase 4Interventional

What this study is about

There are three goals for this study. One is to investigate how different emotions and exposure to cold affect blood flow in the body. The second aim is to study how insulin affects blood flow and tissue glucose uptake, and to study whether this effect is altered in obesity. Last, the study focuses on establishing the lowest dose of a PET radiotracer, oxygen-15 labelled water, that can be used in clinical studies with a new whole-body PET scanner.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 60 Years

SexAll

Healthy volunteersAccepted

ConditionObesity and Overweight

Full registry criteria

Inclusion Criteria: 1. Age 20-60 years 2. BMI either 18.5-25 kg/m2 or above 30 kg/m2 3. Use of hormonal contraception for women in child bearing age Exclusion Criteria: 1. In the lean group history of obesity or type 2 diabetes 2. In the group with obesity: current or previous use of GLP-1-agonists or insulin 3. History of eating disorders 4. Smoking, use of narcotics, excessive use of alcohol 5. Previous participation in PET studies 6. Previous significant exposure to radiation 7. Claustrophobia 8. Active plans for concieving (both sexes) 9. Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results

Treatments and study arms

Movies

Behavioral

Participants will watch eight short movie clips, and the changes different emotions evoked by the clips will be studied using H2\[15O\]O PET/CT.

Cold

Behavioral

Participants will be studied with H2\[15O\]O PET/CT while one of their legs will be exposed to cold to study the effects of cold stimulus on whole-body blood flow.

Hyperinsulinemic euglycemic clamp

Drug

Participants will be administered intravenous fast acting insulin (NovoRapid, Novo Nordisk, 1 mU/m2 body surface area/min) together with 20 % glucose to maintain normal glucose values (5.0 mmol/L) to study the effects of insulin on whole body blood flow with H2\[15O\]O PET/CT, and to assess tissue insulin-stimulated glucose uptake with \[18F\]FDG PET/CT.

H2[15O]O PET/CT

Radiation

H2\[15O\]O PET/CT, with a dose of 25-700 MB/bolus repeated 2-8 times per scan.

[18F]FDG PET/CT

Radiation

Whole-body \[18F\]FDG PET/CT scan to study tissue glucose uptake, dose 100 MBq

CEUS or Contrast enhanced Ultrasound

Drug

Contrast-enhanced ultrasound of left forearm muscles is performed during fasting and after 30-40 minutes of hyperinsulinemia

Primary outcomes

Insulin-induced change in tissue blood flowChange from fasting condition to 10 minutes and 50 minutes after the start of insulin infusion

Brain, liver, skeletal muscle and brain blood-flow (ml/100 g/min) measured with H2\[15O\]O PET/CT

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Turku PET Centre🇫🇮 Turku, Finland

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Pirjo Nuutila, ProfessorContact

Email · Call 35823131868

Sanna Himanen, RNContact

Email · Call +358469200200

Aino Latva-Rasku, MD, PhDSub Investigator