DiabetesPhase 1NCT01789593
A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes
A Phase 1 study testing glucose clamp in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
This trial is conducted in Europe. The aim of the trial is to compare cognitive function and associated brain activation patterns during an acute hypoglycaemic episode and during euglycaemia (normal blood glucose concentration). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- glucose clamp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Jan 2013to 1 Dec 2013
- Phase
- Phase 1
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Right-handed subjects
- Type 1 diabetes mellitus for at least 12 months
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
Who cannot join
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Current tobacco user (any smoking or use of nicotinic products within 3 months prior to screening)
- Visual impairment or auditory impairment
Trial locations and contacts
1 site in 1 country.
About this study
This trial is conducted in Europe. The aim of the trial is to compare cognitive function and associated brain activation patterns during an acute hypoglycaemic episode and during euglycaemia (normal blood glucose concentration). Additionally, the purpose is to assess cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in subjects with type 1 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- glucose clamp
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose clampOther
Each subject will be randomly allocated to an experimental visit sequence consisting of a hypoglycaemic glucose clamp followed by euglycaemic glucose clamp (using i.v. infusion of human soluble insulin (Actrapid®)) or vice versa separated by at least 21 days. Each visit includes an overnight stay. For each of the two conditions (euglycaemia and hypoglycaemia) cognitive performance will be assessed by a validated cognitive test
| Study group | Role | What they receive |
|---|---|---|
| Hypoglycaemia / euglycaemia clamp | Other | Not described Receives: Other: glucose clamp |
| Euglycaemia clamp / hypoglycaemia | Other | Not described Receives: Other: glucose clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digit Symbol Substitution Test (DSST) score
Measured: Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
Secondary outcomes (2)
Regional cerebral blood flow (rCBF) score
Measured: Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
Paced Auditory Serial Addition Task (PASAT) score
Measured: During recovery from hypoglycaemia and/or euglycaemia measured 75-90 min after euglycaemia has been restored
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study start14 Jan 2013
- Primary completion1 Dec 2013
- Study completion1 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789593
- Sponsor's protocol ID
- NN1250-4001
- Other IDs
- U1111-1131-8749
- Status last verified
- Jan 2018
- First submitted
- 25 Jan 2013
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Gejl M, Gjedde A, Brock B, Moller A, van Duinkerken E, Haahr HL, Hansen CT, Chu PL, Stender-Petersen KL, Rungby J. Effects of hypoglycaemia on working memory and regional cerebral blood flow in type 1 diabetes: a randomised, crossover trial. Diabetologia. 2018 Mar;61(3):551-561. doi: 10.1007/s00125-017-4502-1. Epub 2017 Nov 29.
PubMed 29188338
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01789593
- Acronym / sponsor ID
- NN1250-4001
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2013 (actual)
- Primary completion
- 1 Dec 2013 (actual)
- Study completion
- 1 Dec 2013 (actual)
- First posted
- 12 Feb 2013 (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.
This trial is conducted in Europe. The aim of the trial is to compare cognitive function and associated brain activation patterns during an acute hypoglycaemic episode and during euglycaemia (normal blood glucose concentration). Additionally, the purpose is to assess cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in subjects with type 1 diabetes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoglycaemia / euglycaemia clamp | Other | Other: glucose clamp |
| Euglycaemia clamp / hypoglycaemia | Other | Other: glucose clamp |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Right-handed subjects
- Type 1 diabetes mellitus for at least 12 months
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
Key exclusion criteria (3 listed)
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Current tobacco user (any smoking or use of nicotinic products within 3 months prior to screening)
- Visual impairment or auditory impairment
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 |
|---|---|---|
| glucose clampEach subject will be randomly allocated to an experimental visit sequence consisting of a hypoglycaemic glucose clamp followed by euglycaemic glucose clamp (using i.v. infusion of human soluble insulin (Actrapid®)) or vice versa separated by at least 21 days. Each visit includes an overnight stay. For each of the two conditions (euglycaemia and hypoglycaemia) cognitive performance will be assessed by a validated cognitive test | Other | Euglycaemia clamp / hypoglycaemia, Hypoglycaemia / euglycaemia clamp |
Primary outcome
Digit Symbol Substitution Test (DSST) score
Time frame: Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
2 secondary outcomes
Regional cerebral blood flow (rCBF) score
Time frame: Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
Paced Auditory Serial Addition Task (PASAT) score
Time frame: During recovery from hypoglycaemia and/or euglycaemia measured 75-90 min after euglycaemia has been restored
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 12 Jan 2018.
- Results publication: PubMed 29188338Gejl M, Gjedde A, Brock B, Moller A, van Duinkerken E, Haahr HL, Hansen CT, Chu PL, Stender-Petersen KL, Rungby J. Effects of hypoglycaemia on working memory and regional cerebral blood flow in type 1 diabetes: a randomised, crossover trial. Diabetologia. 2018 Mar;61(3):551-561. doi: 10.1007/s00125-017-4502-1. Epub 2017 Nov 29.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing glucose clamp in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Denmark.
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 4 inclusion and 3 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 12 Jan 2018. 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 Denmark. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Digit Symbol Substitution Test (DSST) score (time frame: Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia). 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 NCT01789593, which also lists 1 linked publication.
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 12 Jan 2018.