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Activity of brown adipose tissue during hypoglycaemia.


- candidate number9087
- NTR NumberNTR2744
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-feb-2011
- Secondary IDsMEC 10/295 METC AMC
- Public TitleActivity of brown adipose tissue during hypoglycaemia.
- Scientific TitleActivity of Brown Adipose Tissue during hypoglycaEmia.
- ACRONYMABATE
- hypothesisWe hypothesise that there is a central mechanism that shuts down energy consumption by brown adipose tissue (BAT) during hypoglycaemia. This could be a mechanism to protect the brain from neuroglycopenia.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 1 (DM type I), Brown Adipose Tissue, Thermoregulation
- Inclusion criteriaInclusion criteria for healthy volunteers:
1. Male;
2. Caucasian race;
3. 18-50 years old;
4. BMI 20-28 kg/m2;
5. Subjects should be able and willing to give informed consent.

Inclusion criteria for type 1 Diabetes patients:
1. Male;
2. Caucasian race;
3. Age 18-50 years;
4. BMI 20-28 kg/m2;
5. Type 1 Diabetes Mellitus;
6. Subjects should be able and willing to give informed consent.
- Exclusion criteriaExclusion criteria for healthy volunteers:
1. Use of prescription medication (beta-adrenoreceptor blockers);
2. Cardiac history (previous arrhythmia);
3. History of epilepsy;
4. Acute illness within 3 months before the study;
5. Significant renal impairment (creatinin clearance <50ml/min);
6. Family history of diabetes.

Exclusion criteria for type 1 Diabetes patients:
1. Impaired awareness of hypoglycaemia;
2. Evidence of severe diabetes complications (autonomic neuropathy, macroalbuminuria, proliferative retinopathy);
3. Use of beta-adrenoreceptor blockers;
4. Cardiac history (previous arrhythmia);
5. History of epilepsy;
6. Acute illness within 3 months before the study;
7. Significant renal impairment (creatinin clearance <50ml/min).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mrt-2011
- planned closingdate1-mrt-2013
- Target number of participants16
- InterventionsTwo 18F-FDG PET-CT scans per patient will be performed of the upper body half to visualise the activity of BAT. The first scan will be performed following a hyperinsulinaemic normoglycaemic clamp and the second scan will be performed following a hyperinsulinaemic hypoglycaemic clamp (separated from the first scan by at least 2 weeks).
- Primary outcome1. Change in Standardised Uptake Value (SUV) of the tracer [18F]-fluorodeoxyglucose (FDG) visualised with positron emission tomography (PET) in BAT (normoglycaemia vs. hypoglycaemia);
2. Change in Standardised Uptake Value (SUV) of the tracer [18F]-fluorodeoxyglucose (FDG) visualised with positron emission tomography (PET) in BAT (healty volunteers vs. type 1 Diabetes patients).
- Secondary outcomeN/A
- TimepointsScans are performed within a minimum of 2 weeks apart.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES F. Holleman
- CONTACT for SCIENTIFIC QUERIES F. Holleman
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Stichting Asklepios
- PublicationsN/A
- Brief summaryBrown adipose tissue activity and shivering thermogenesis are considered as two important heat producing mechanisms. Shivering to cold in healthy adults is known to stop when plasma glucose falls below 2.5 mmol/L (insulin induced) and as a result core temperature decreases. We hypothesize that brown adipose tissue activity diminishes during hypoglycaemia.
- Main changes (audit trail)
- RECORD9-feb-2011 - 6-aug-2014


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