Skip to main content
OpenTrials
Completed

NCT Number: NCT00626080

Insulin Detemir Action in Cerebro

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

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

Other names: Insulin Levemir

insulin NPH

Drug

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

Other names: Insulin Insulatard

Primary outcomes

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

    Time frame: After 12 weeks of treatment

  2. Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET

    Time frame: After 12 weeks of treatment

Secondary outcomes

  1. CSF insulin concentration

    Time frame: After 12 weeks of treatment

  2. Activity in brain regions associated with appetite control, as determined by fMRI

    Time frame: After 12 weeks of treatment

  3. Weight change

    Time frame: After 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

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

Acronym: INcEREBRO

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 29, 2008
Registry last updated
Dec 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.