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Kan warmte post-prandiale endotheel dysfunctie voorkomen?


- candidate number18046
- NTR NumberNTR4631
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jun-2014
- Secondary IDs2013-536 CMO
- Public TitleKan warmte post-prandiale endotheel dysfunctie voorkomen?
- Scientific TitleCan heating prevent hyperglycaemia-induced endothelial dysfunction?
- ACRONYMOGTT-heat
- hypothesisWarmte zorgt voor toename van de doorbloeding, welke lokaal een afname van de endotheelfunctie na een maaltijd kan voorkomen.
- Healt Condition(s) or Problem(s) studiedEndothelial dysfunction
- Inclusion criteriaDiabetes group:
- Older than 40 years
- Diagnosed with type 2 diabetes mellitus at least 2 years ago
Control group:
- Older than 40 years (ensure matching with diabetes group at group level)
- Exclusion criteriaDiabetes group:
- Women
- Cardiovascular disease
- Hypercholesterolemia
- Hypertension (>160 mmHg systolic and/or >90 mmHg diastolic pressure) and/or subjects on antihypertensive drugs
- Smoking
- Type I diabetes mellitus
- Older than 70 years
- Subjects with vascular complications due to type 2 diabetes mellitus (e.g. diabetic foot ulcer)
- Subjects using insulin injections to regulate glucose homeostasis
Control group:
- Women
- Cardiovascular disease
- Hypercholesterolemia
- Hypertension (>160 mmHg systolic and/or >90 mmHg diastolic pressure) and/or subjects on antihypertensive drugs
- Smoking
- Older than 70 years
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-jan-2014
- planned closingdate31-dec-2014
- Target number of participants20
- InterventionsLocal heating
- Primary outcomeChange in endothelial function (measured as flow-mediatd dilation) after a meal (induced by 75-gr glucose ingestion)
- Secondary outcomeBlood flow and skin temperature changs
- TimepointsBefore and after (1, 2 and 2.5 h) 75-gr glucose
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Dick H.J. Thijssen
- CONTACT for SCIENTIFIC QUERIESDr. Dick H.J. Thijssen
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Nijmegen, Unilever
- Publications
- Brief summaryRationale:
Endothelial dysfunction contributes to the development of vascular complications in type 2 Diabetes Mellitus (T2DM). Elevation in glucose level (i.e. hyperglycaemia) is demonstrated to contribute to a transient decrease in endothelial function, especially in T2DM as these subjects demonstrate prolonged hyperglycaemia after a glucose load compared to healthy controls.
In previous studies, we have demonstrated that elevation in blood flow can improve endothelial function in healthy subjects. Accordingly, elevation in blood flow may also counteract the impact of hyperglycaemia on endothelial function in T2DM and their age-matched controls.
Objectives:
To examine whether heating can prevent the hyperglycaemia-induced decline in endothelial function in T2DM and age -matched controls.
Study design:
Cross-sectional observational study
Study population:
10 subjects with T2DM and 10 age -matched controls
Intervention (if applicable):
Not applicable
Main study parameters/endpoints:
The change in endothelial function after 75-gr glucose (measured as the brachial artery flow-mediated dilation at 3 distinct time-points).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
We will take a total of four venous blood samples from each subject. Taking a blood sample is associated with a 5% risk of developing a haemorrhage, which is not associated with any functional limitations and will disappear within 2 weeks. To minimise the potential risk, a venous ‘line’ is introduced once which facilitates repeated venous blood withdrawals. Other measures/interventions (75 gr glucose load, heating, echo-Doppler, 5-minutes cuff inflation) are not associated with any potential health risk.
- Main changes (audit trail)
- RECORD6-jun-2014 - 2-jul-2014


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