Insulin Detemir Action in Cerebro (INcEREBRO)

Amsterdam UMC, location VUmc

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Drug: Insulin NPH; Drug: Insulin detemir

Study type: Interventional

Funder types: Other

Identifiers

NCT00626080

DC2007Det001

2007-007255-13

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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