Type 1 DiabetesINcEREBRONCT00626080
Insulin Detemir Action in Cerebro
A study testing Insulin detemir and Insulin NPH in people with Type 1 Diabetes, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin detemir and Insulin NPH
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Type 1 diabetic patients;
- Diabetes duration =/> 1 year;
- HbA1c ~ 7,5%;
Who cannot join
- 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;
Show all 15Show fewer
- (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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of INsulin dEtemiR and Neutral protaminE Hagedorn (NPH) Insulin on BRain glucOse Metabolism: a Study in Persons With Type 1 Diabetes
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin detemir, Insulin NPH
- Keywords
- Insulin, Detemir, Brain, Glucose metabolism
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin detemirDrug
Also called Insulin Levemir
100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID
Insulin NPHDrug
Also called Insulin Insulatard
100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET
Measured: After 12 weeks of treatment
Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET
Measured: After 12 weeks of treatment
Secondary outcomes (3)
CSF insulin concentration
Measured: After 12 weeks of treatment
Activity in brain regions associated with appetite control, as determined by fMRI
Measured: After 12 weeks of treatment
Weight change
Measured: After 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Investigators
- Michaela Diamant, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626080
- Sponsor's protocol ID
- DC2007Det001
- Other IDs
- 2007-007255-13
- Acronym
- INcEREBRO
- Status last verified
- Dec 2011
- First submitted
- 19 Feb 2008
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
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 24739875van 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 24130356van 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 23530004Huisman 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of INsulin dEtemiR and Neutral protaminE Hagedorn (NPH) Insulin on BRain glucOse Metabolism: a Study in Persons With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00626080
- Acronym / sponsor ID
- INcEREBRO / DC2007Det001
- Conditions
- Type 1 Diabetes
- Keywords
- Insulin, Detemir, Brain, Glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Type 1 diabetic patients;
- Diabetes duration =/> 1 year;
- HbA1c ~ 7,5%;
Key exclusion criteria (15 listed)
- Recent onset of DM;
- BMI < 18 OR > 35 kg/m2;
- T2DM;
- History of major heart/renal disease;
- Severe untreated proliferative retinopathy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin detemirAlso: Insulin Levemir100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID | Drug | – |
| Insulin NPHAlso: Insulin Insulatard100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID | Drug | – |
Primary outcome
Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET
Time frame: After 12 weeks of treatment
Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET
Time frame: After 12 weeks of treatment
3 secondary outcomes
CSF insulin concentration
Time frame: After 12 weeks of treatment
Activity in brain regions associated with appetite control, as determined by fMRI
Time frame: After 12 weeks of treatment
Weight change
Time frame: After 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2011.
- Derived from this study: PubMed 24739875van 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.
- Derived from this study: PubMed 24130356van 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.
- Derived from this study: PubMed 23530004van 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.
- Derived from this study: PubMed 23168248Huisman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Diamant, MD, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin detemir and Insulin NPH in people with Type 1 Diabetes, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET (time frame: After 12 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00626080, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2011.