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Insulin Detemir Action in Cerebro

NCT ID: NCT00626080

Last Updated: 2011-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Keywords

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Insulin Detemir Brain Glucose metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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Insulin detemir

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

Intervention Type DRUG

Insulin NPH

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

Intervention Type DRUG

Other Intervention Names

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Insulin Levemir Insulin Insulatard

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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VU University Medical Center

Principal Investigators

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Michaela Diamant, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

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VU University Medical Center

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 24739875 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24130356 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23530004 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23168248 (View on PubMed)

Other Identifiers

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2007-007255-13

Identifier Type: -

Identifier Source: secondary_id

DC2007Det001

Identifier Type: -

Identifier Source: org_study_id