Clinical trial NCT00626080: Insulin Detemir Action in Cerebro
Official title: Effects of INsulin dEtemiR and Neutral protaminE Hagedorn (NPH) Insulin on BRain glucOse Metabolism: a Study in Persons With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Insulin
Detemir
Brain
Glucose metabolism
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of this study is to test the hypothesis that subcutaneous administration of insulin detemir, as compared to insulin NPH, leads to a more pronounced effect on cerebral glucose metabolism and/or cerebral blood flow in brain regions associated with appetite regulation, to account for the reported difference in weight.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetic patients;
* Diabetes duration =/\> 1 year;
* HbA1c \~ 7,5%;

Exclusion Criteria:

* Recent onset of DM;
* BMI \< 18 OR \> 35 kg/m2;
* T2DM;
* History of major heart/renal disease;
* Severe untreated proliferative retinopathy;
* History of recurrent severe hypoglycaemia;
* (History of) brain disorders;
* Alcohol abuse,(History of) drug abuse, benzodiazepines, selective beta-blockers, oral steroids, oral anticoagulants;
* Current psychiatric disease/treatment;
* (history of) eating disorders;
* History of severe head trauma accompanied by loss of consciousness;
* Any endocrine disease not well controlled for at least 3 months;
* Inability to undergo MRI;
* Visual acuity \< 0.3;
* Known or suspected allergy to trial product or related products

Primary outcomes:
measure: Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET
timeFrame: After 12 weeks of treatment
measure: Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: CSF insulin concentration
timeFrame: After 12 weeks of treatment
measure: Activity in brain regions associated with appetite control, as determined by fMRI
timeFrame: After 12 weeks of treatment
measure: Weight change
timeFrame: After 12 weeks of treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Michaela Diamant, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Golen LW, Veltman DJ, IJzerman RG, Deijen JB, Heijboer AC, Barkhof F, Drent ML, Diamant M. Effects of insulin detemir and NPH insulin on body weight and appetite-regulating brain regions in human type 1 diabetes: a randomized controlled trial. PLoS One. 2014 Apr 16;9(4):e94483. doi: 10.1371/journal.pone.0094483. eCollection 2014.
citation: van Golen LW, IJzerman RG, Huisman MC, Hensbergen JF, Hoogma RP, Drent ML, Lammertsma AA, Diamant M. Cerebral blood flow and glucose metabolism in appetite-related brain regions in type 1 diabetic patients after treatment with insulin detemir and NPH insulin: a randomized controlled crossover trial. Diabetes Care. 2013 Dec;36(12):4050-6. doi: 10.2337/dc13-0093. Epub 2013 Oct 15.
citation: van Golen LW, Huisman MC, Ijzerman RG, Hoetjes NJ, Schwarte LA, Lammertsma AA, Diamant M. Cerebral blood flow and glucose metabolism measured with positron emission tomography are decreased in human type 1 diabetes. Diabetes. 2013 Aug;62(8):2898-904. doi: 10.2337/db12-1159. Epub 2013 Mar 25.
citation: Huisman MC, van Golen LW, Hoetjes NJ, Greuter HN, Schober P, Ijzerman RG, Diamant M, Lammertsma AA. Cerebral blood flow and glucose metabolism in healthy volunteers measured using a high-resolution PET scanner. EJNMMI Res. 2012 Nov 20;2(1):63. doi: 10.1186/2191-219X-2-63.