Effects of INsulin dEtemiR and neutral protaminE hagedorn (nph) insulin on BRain glucOse metabolism: a study in persons with type 1 diabetes
Completed
- Conditions
- type 1 diabetes10018424
- Registration Number
- NL-OMON33980
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Type 1 diabetic patients
Age 21-60 years
Male
Diabetes duration minimal 2 years
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 steoids, 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study endpoints:<br /><br>I. Cerebral metabolic rate of glucose (CMRglu), in brain regions associated<br /><br>with appetite regulation, as determined by FDG-PET scanning<br /><br>II. Cerebral blood flow (CBF), in brain regions associated with appetite<br /><br>regulation, as determined by H2O-PET scanning</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study endpoints:<br /><br>I. Insulin concentrations in the CSF<br /><br>II. Brain activity in specific regions involved in control of appetite, as<br /><br>determined by fMRI<br /><br>III. Weight change </p><br>