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CompletedNCT00626080INcEREBROUpdated Dec 30, 2011

Insulin Detemir Action in Cerebro

An interventional study of Insulin detemir and Insulin NPH in Type 1 Diabetes, sponsored by Amsterdam UMC, location VUmc. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-30.

Sponsored by Amsterdam UMC, location VUmc · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
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Study summary

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.

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Conditions studied

  • Type 1 Diabetes

Keywords

  • Insulin
  • Detemir
  • Brain
  • Glucose metabolism
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Type 1 diabetic patients;
  • Diabetes duration =/> 1 year;
  • HbA1c \~ 7,5%;

Exclusion criteria

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
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Interventions

  • DrugInsulin detemir

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

    Also known as: Insulin Levemir

  • DrugInsulin NPH

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

    Also known as: Insulin Insulatard

06

What researchers measure

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

07

Study locations

1 site
  • VU University Medical Center
    Amsterdam, 1081 HV, Netherlands
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References and documents

Publications

  • van Golen LW, Veltman DJ, IJzerman RG, Deijen JB, Heijboer AC, Barkhof F, Drent ML, Diamant M. Effects of insulin detemir and NPH insulin on body weight and appetite-regulating brain regions in human type 1 diabetes: a randomized controlled trial. PLoS One. 2014 Apr 16;9(4):e94483. doi: 10.1371/journal.pone.0094483. eCollection 2014. PubMed 24739875 ↗
  • van Golen LW, IJzerman RG, Huisman MC, Hensbergen JF, Hoogma RP, Drent ML, Lammertsma AA, Diamant M. Cerebral blood flow and glucose metabolism in appetite-related brain regions in type 1 diabetic patients after treatment with insulin detemir and NPH insulin: a randomized controlled crossover trial. Diabetes Care. 2013 Dec;36(12):4050-6. doi: 10.2337/dc13-0093. Epub 2013 Oct 15. PubMed 24130356 ↗
  • van Golen LW, Huisman MC, Ijzerman RG, Hoetjes NJ, Schwarte LA, Lammertsma AA, Diamant M. Cerebral blood flow and glucose metabolism measured with positron emission tomography are decreased in human type 1 diabetes. Diabetes. 2013 Aug;62(8):2898-904. doi: 10.2337/db12-1159. Epub 2013 Mar 25. PubMed 23530004 ↗
  • Huisman MC, van Golen LW, Hoetjes NJ, Greuter HN, Schober P, Ijzerman RG, Diamant M, Lammertsma AA. Cerebral blood flow and glucose metabolism in healthy volunteers measured using a high-resolution PET scanner. EJNMMI Res. 2012 Nov 20;2(1):63. doi: 10.1186/2191-219X-2-63. PubMed 23168248 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00626080
Lead sponsor
Amsterdam UMC, location VUmc
First posted
Feb 29, 2008
Start date
Jan 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Dec 30, 2011

Study contacts

Michaela Diamant, MD, PhD
principal investigator · Amsterdam UMC, location VUmc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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