No registrations found.
ID
Source
Brief title
Health condition
Type 1 Diabetes, Brown Adipose Tissue, Thermoregulation,
Type 1 Diabetes, bruin vet, thermoregulatie
Sponsors and support
J.B.L. Hoekstra
Intervention
Outcome measures
Primary outcome
1. 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 outcome
N/A
Background summary
Brown 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.
Study objective
We 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.
Study design
Scans are performed within a minimum of 2 weeks apart.
Intervention
Two 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).
F. Holleman
AMC, Room F4-222
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665954
F.Holleman@amc.uva.nl
F. Holleman
AMC, Room F4-222
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665954
F.Holleman@amc.uva.nl
Inclusion criteria
Inclusion 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 criteria
Exclusion 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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2616 |
| NTR-old | NTR2744 |
| Other | METC AMC : MEC 10/295 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |