Insulin Detemir Action in Cerebro

Effects of INsulin dEtemiR and Neutral protaminE Hagedorn (NPH) Insulin on BRain glucOse Metabolism: a Study in Persons With Type 1 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00626080

Acronym

INcEREBRO

Enrollment

Registered

2008-02-29

Start date

2009-01-31

Completion date

2011-12-31

Last updated

2011-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Insulin, Detemir, Brain, Glucose metabolism

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.

Interventions

DRUGInsulin detemir

100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID

DRUGInsulin NPH

100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET	After 12 weeks of treatment
Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET	After 12 weeks of treatment

Secondary

Measure	Time frame
CSF insulin concentration	After 12 weeks of treatment
Activity in brain regions associated with appetite control, as determined by fMRI	After 12 weeks of treatment
Weight change	After 12 weeks of treatment

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026