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PVAT and skeletal muscle insulin sensitivity

Determination of the effect of perivascular adipose tissue on insulin-stimulated skeletal muscle glucose uptake in prediabetes by PET-CT - PVAT and skeletal muscle insulin sensitivity

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57348
Enrollment
30
Registered
2024-09-13
Start date
2025-06-02
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus, diabetes Diabetes

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Caucasian (people will be excluded when having a >=50% racial African/Asian background); 2. Male or (postmenopausal; defined as 1 year after the last cycle) female; 3. Age between 40-75 years; 4. BMI: 25-35 kg/m2; 5. Pre-diabetes in one the following criteria: a. Impaired glucose tolerance: plasma glucose values >= 7.8 mmol/l and = 6.1 mmol/l and 3kg in the past 3 months); 7. Sedentary lifestyle (not more than 2 hours of vigorous exercise per week).

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded  from participation in this study: 1. Not meeting all inclusion criteria; 2. Type 2 diabetes (fasted blood glucose > 7 mmol/L or non-fasted > 11mmol/L); 3. Any condition, disease or abnormal laboratory test result that, in the  opinion of the Investigator, would interfere with the study outcome, affect  trial participation or put the subject at undue risk. 4. Alcohol consumption of >2 servings per day;  5. Currently smoking or having quit recently; 6. Low Hb (men: <8.6 mmol/L; women <7.4 mmol/L); 7. Subjects using anticoagulant medication (antiplatelet agents can be used,  but other medications should be excluded);  8. Subjects who have participated in another biomedical study within the last 3  months that could interfere with the study results; 9. Subjects were involved in previous research that included PET/CT scanning; 10. Participants who do not want to be informed about unexpected medical  findings; * 11. Participants who do not want that their treating physician to be informed; 12. Inability to participate and/or complete the required measurements; 13. Participation in organised or structured physical exercise (>2h per week); 14. Allergic or hypersensitive to iodine-containing contrast medium.

Design outcomes

Primary

MeasureTime frame
Primary outcome parameter is insulin-stimulated 18F-FDG uptake in quadriceps muscle (expressed as Ki) as measured by means of [18F]-FDG PET and PVAT quantity and inflammation measured by CT angiography.

Secondary

MeasureTime frame
Secondary study parameters are: - Skeletal muscle blood flow measured by contrast enhanced ultrasonography (CEUS); - Hepatic, myocardial, and whole-body glucose uptake rate (Ki) measured with PET-CT; - Skeletal muscle mitochondrial function measured by means of Oroboros in skeletal muscle biopsies; - Skeletal muscle intracellular insulin signalling pathways measured by Western blot in muscle biopsies.

Countries

Netherlands

Contacts

Public ContactP.M.G. van Lier

Universiteit Maastricht

t.vandeweijer@maastrichtuniversity.nl+31 6 13 69 14 59

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026