Insulin Detemir Action in Cerebro

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Insulin detemir
* Drug: Insulin NPH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin detemir|100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID|
|Drug: Insulin NPH|100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin, Detemir, Brain, Glucose metabolism