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18F-FDG uptake, as marker of inflammation/metabolic activity, in vasculature and VAT and SAT.


- candidate number29614
- NTR NumberNTR7687
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-okt-2018
- Secondary IDs201700731 Research register UMCG
- Public Title18F-FDG uptake, as marker of inflammation/metabolic activity, in vasculature and VAT and SAT.
- Scientific Title18F-FDG uptake, as marker of inflammation/metabolic activity, in vasculature and VAT and SAT.
- ACRONYMRELEASE study
- hypothesisWe hypothesize that 18F-FDG is a valide marker for metabolic activity in adipose tissue and even more pronounced in type 2 diabetes.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Obesity
- Inclusion criteria- Men and woman
- Age above 17 years
- Exclusion criteria- Age below 18 years
- Incompetent
- Type 1 diabetes
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2018
- planned closingdate1-jul-2019
- Target number of participants60
- InterventionsNot applicable
- Primary outcome• Compared associations between CVD risk factors and abdominal adipose tissue volume
• The association between abdominal adipose tissue and arterial inflammation
• 18F-FDG adipose tissue uptake differences between VAT and SAT
- Secondary outcome• The influence type 2 diabetes on 18F-FDG uptake
- TimepointsT0= informed consent
T1= venapuncture and 18F-FDG PET/CT scan
- Trial web siteNot applicable
- status[default]
- CONTACT FOR PUBLIC QUERIES M. Reijrink
- CONTACT for SCIENTIFIC QUERIES M. Reijrink
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Boehringer Ingelheim
- Publications1: Effect of linagliptin on pulse wave velocity in early type 2 diabetes: A randomized, double-blind, controlled 26-week trial (RELEASE). de Boer SA, Heerspink HJL, Juárez Orozco LE, van Roon AM, Kamphuisen PW, Smit AJ, Slart RHJA, Lefrandt JD, Mulder DJ. Diabetes Obes Metab. 2017 Aug;19(8):1147-1154. doi: 10.1111/dom.12925

2: Effect of Linagliptin on Arterial 18F-Fluorodeoxyglucose Positron Emission Tomography Uptake: A Randomized Controlled Trial (RELEASE). de Boer SA, Heerspink HJ, Lefrandt JD, Hovinga-de Boer MC, van Roon AM, Juárez Orozco LE, Glaudemans AW, Kamphuisen PW, Slart RH, Mulder DJ. J Am Coll Cardiol. 2017 Feb 28;69(8):1097-1098. doi: 10.1016/j.jacc.2016.12.018
- Brief summaryAlready early in the course of their disease, patients with type 2 diabetes (T2D) have considerably increased cardiovascular risk, irrespective of glycemic control. Visceral adipose tissue (VAT) is thought to play an important role, by inducing insulin resistance (IR) and non-alcoholic fatty liver disease (NAFLD) and by being metabolically active and producing adipocytokines. Its contribution to early atherosclerosis development is not fully understood. We investigated the association between VAT volume and subclinical arterial inflammation in early T2D patients by using 18F-fluordeoxyglucose (FDG) positron emission tomography (PET) with low dose computed tomography (CT) and performed a pilot to explore the value of FDG-uptake in VAT as a proxy for its metabolic activity.
Furthermore, to study whether VAT in diabetic subjects is inflamed, ex vivo 18F-FDG uptake will be determined using PET and compared with uptake in VAT and SAT.
- Main changes (audit trail)
- RECORD1-okt-2018 - 2-jan-2019


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