NCT01789593

Brief 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). Additionally, the purpose is to assess cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in subjects with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Jan 2013

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

January 25, 2013

Last Update Submit

January 11, 2018

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Digit Symbol Substitution Test (DSST) score

    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

    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

    During recovery from hypoglycaemia and/or euglycaemia measured 75-90 min after euglycaemia has been restored

Study Arms (2)

Hypoglycaemia / euglycaemia clamp

OTHER
Other: glucose clamp

Euglycaemia clamp / hypoglycaemia

OTHER
Other: glucose clamp

Interventions

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

Euglycaemia clamp / hypoglycaemiaHypoglycaemia / euglycaemia clamp

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Århus C, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 29188338RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Glucose Clamp Technique

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

February 12, 2013

Study Start

January 14, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

DK(1)