Total-body Glucose Utilization in Obesity

NCT06739473 | Recruiting Phase 4

• 1 other identifier: T335/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity and Overweight

Keywords

obesity; radiowater; PET

Outcome Measures

Primary Outcomes (1)

• Insulin-induced change in tissue blood flow

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

  Change from fasting condition to 10 minutes and 50 minutes after the start of insulin infusion

Secondary Outcomes (4)

• Effects of insulin on skeletal muscle microvascular perfusion

  Change from fasting condition to 10 minutes and 50 minutes after the start of insulin infusion

• Tissue insulin-stimulated glucose uptake

  Measured from 60 to 110 minutes after the start of insulin infusion

• Effects of emotions on whole-body blood flow

  Measured during 60-second activation blocks (visual stimuli) or during 5 min cold-exposure

• Range of effective and feasible radiowater doses with whole-body PET/CT

  During repetitive H2[15O]O scans (a total of 120 minutes)

Study Arms (2)

TOTAL dose test

EXPERIMENTAL

The aim of the studies performed in this arm (8 subjects) is to test the lowest dose of H2\[15O\]O (radiowater) for the Siemens Quadra PET/CT scanner. Each participant will be studied once with the scanner with 4 different doses (25-700 MBq) of H2\[15O\]O, each repeated 2 times

Radiation: H2[15O]O PET/CT

TOTAL

EXPERIMENTAL

The participants in this arm will undergo two PET visits. On one visit the effects of visual stimuli or cold on whole body perfusion will be studied with H2\[15O\]O PET/CT. On the second visit whole-body insulin sensitivity is studied with \[18F\]fluorodeoxyglucose PET/CT, and the acute and delayed effects of intravenous insulin on blood flow will be studied with H2\[15O\]O PET/CT.

Behavioral: Movies; Behavioral: Cold; Drug: Hyperinsulinemic euglycemic clamp; Radiation: H2[15O]O PET/CT; Radiation: [18F]FDG PET/CT; Drug: CEUS or Contrast enhanced Ultrasound

Interventions

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.

TOTAL

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.

TOTAL

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.

TOTAL

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.

TOTAL; TOTAL dose test

[18F]FDG PET/CT RADIATION

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

TOTAL

CEUS or Contrast enhanced Ultrasound DRUG

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

TOTAL

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-60 years
• BMI either 18.5-25 kg/m2 or above 30 kg/m2
• Use of hormonal contraception for women in child bearing age

You may not qualify if:

• In the lean group history of obesity or type 2 diabetes
• In the group with obesity: current or previous use of GLP-1-agonists or insulin
• History of eating disorders
• Smoking, use of narcotics, excessive use of alcohol
• Previous participation in PET studies
• Previous significant exposure to radiation
• Claustrophobia
• Active plans for concieving (both sexes)
• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku PET Centre

Turku, 20521, Finland

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Motion Pictures; Cold Temperature

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Lauri Nummenmaa, Professor

  University of Turku

  PRINCIPAL INVESTIGATOR

• Pirjo Nuutila, professor

  University of Turku, Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aino Latva-Rasku, MD, PhD

CONTACT

358+23139857; aehyyp@utu.fi

Sanna Himanen, RN

CONTACT

358+469200200; sanna.himanen@varha.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: December 18, 2024
• Study Start: January 25, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)