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van CCT (UK)

Morfologie en functie van de hypothalamus na inname van water en drinkmaaltijd.

- candidate number5522
- NTR NumberNTR1741
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mrt-2009
- Secondary IDsP08.224 METC LUMC
- Public TitleMorfologie en functie van de hypothalamus na inname van water en drinkmaaltijd.
- Scientific TitleHypothalamic neuronal activity in response to a mixed meal versus water ingestion.
- hypothesisWe hypothesize that the hypothalamic neuronal activity in response to water is different in response to a mixed meal.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus
- Inclusion criteria1. Healthy males;
2. Age 19-29;
3. BMI 19-25 kg/m2;
4. Stable weight for the last 2 years;
5. Caucasian;
6. No family history of DM2.
- Exclusion criteria1. Use of medication known to affect glucose metabolism (for example prednison) or lipid metabolism;
2. History of genetic or psychiatric disease (e.g. fragile X syndrome, major depression) that affects the brain;
3. Significant chronic disease;
4. Galactosemia;
5. Renal or hepatic disease;
6. Recent weight changes or attempts to lose or gain weight (> 3 kg weight gain or loss, within the last 3 months);
7. Smoking (current);
8. Alcohol consumption of more than 28 units per week at present or in the past;
9. Recent blood donation (within the last 3 months);
10. Contra-indication to MRI scanning:
A. Claustrophobia;
B. Pacemakers and defibrillators;
C. Nerve stimulators;
D. Intracranial clips;
E. Intraorbital or intraocular metallic fragments;
F. Cochlear implants;
E. Ferromagnetic implants.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-jan-2009
- planned closingdate1-apr-2009
- Target number of participants10
- InterventionsDrinking nutridrink or water while a FMRI is being made.
- Primary outcomeHypothalamic neuronal activity as measured with FMRI.
- Secondary outcomeN/A
- TimepointsStart date 20-01-2009.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESarts-onderzoeker M.A. Wijngaarden
- CONTACT for SCIENTIFIC QUERIESarts-onderzoeker M.A. Wijngaarden
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryIt has long been recognized that the hypothalamus plays a crucial role in metabolism. It is thought that the hypothalamus and brain stem get input from the periphery about the available food sources and that, thereafter, efferent neuroendocrine systems come in action to regulate food intake.

Several groups have focused on the effect of glucose ingestion on blood oxygen level-dependent (BOLD) signals in the hypothalamus (detected by MRI). Although there have been some contradicting papers, most studies found that the BOLD signal is diminished after the ingestion of glucose.

In future studies it would be more elegant to study the effects of a mixed meal on hypothalamic neuronal activity (before and after interventions), since this resembles the physiological stimulus (food) more closely. Thus far, the effects of a mixed meal on hypothalamic neuronal activity as measured by fMRI (BOLD) have not been established. Therefore, we will study the effects of a mixed meal versus water on hypothalamic neuronal activity.
- Main changes (audit trail)
- RECORD27-mrt-2009 - 23-sep-2009

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