Insulin Detemir Action in Cerebro

Amsterdam UMC, location VUmc40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Insulin detemirDRUG

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

Insulin NPHDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

VU University Medical Center

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET