Adipose Tissue Imaging in Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02528695
• Date of registration: 18/08/2015
• Prospective Registration: No
• Primary sponsor: Radboud University
• Public title: Adipose Tissue Imaging in Type 2 Diabetes ATI-DM2
• Scientific title: Adipose Tissue Imaging in Patients With Type 2 Diabetes, Pilot Study
• Date of first enrolment: November 2014
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02528695
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Netherlands

Contacts

• Name: Martin Gotthardt, Prof. Dr.
• Affiliation: Radboud University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > 18 years

- BMI 27-40

For healthy volunteers:

- Fasting blood glucose < 6.1 mmol/L

- HbA1c < 42 mmol/mol (6%)

For T2D patients:

- Clinical overt Type 2 Diabetes

- on a glucose-lowering diet or on oral glucose-lowering medication

- T2D stable and under control for minimal 2 years

- HbA1c < 75 mmol/mol (9%)

Exclusion Criteria:

- Renal dysfunction

- Overt symptomatic neuropathy or proliferative retinopathy

- A history of cardiovascular disease complications (myocardial infarction, stroke,
peripheral artery disease)

- Pregnancy or lactating

- Using subcutaneous insulin

- Incapability to provide informed consent



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus Type 2

Intervention(s)

Device: euglycemic clamp

Device: hypoglycemic clamp

Radiation: 18F-FDG PET/CT

Primary Outcome(s)

Glucose uptake in adipose tissue measured by uptake of 18F-FDG on PET images [Time Frame: 1 year]

Secondary ID(s)

NL44098.091.13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors