Recurrent Hypoglycaemia in Type 1 Diabetes (HypoNeuro)

This study has been completed.
Sponsor:
Collaborators:
University of Southern Denmark
Rigshospitalet, Denmark
Hypo-Safe A/S
Information provided by (Responsible Party):
Anne-Sophie Sejling, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01337362
First received: March 30, 2011
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

Patients with type 1 diabetes are at risk of very low blood sugar levels (hypoglycaemia) as a severe side effect to insulin therapy, in particular subjects who have lost warning of hypoglycaemia. During hypoglycaemia a low frequent activity can be seen with electroencephalography (EEG) as cognitive function declines.

The purpose of the study is to investigate the activity in the brain, the cognitive function, and the skin temperature when patients are exposed to repeated hypoglycaemia. The results will show whether the response to hypoglycaemia will change after repeated episodes.

It is our hope that results can contribute to improved understanding of hypoglycaemic EEG changes.


Condition Intervention
Hypoglycaemia
Procedure: Insulin clamp

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Recurrent Hypoglycaemia in Type 1 Diabetes: Effects on Cognitive Function, Cerebral Electrical Activity, and Skin Temperature

Resource links provided by NLM:


Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • EEG [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    EEG will be analysed in order to see whether there are any differences between aware and unaware patients during hypoglycaemia. It is our hope that the result can help develop an alarm before the patient experiences severe hypoglycaemia.


Secondary Outcome Measures:
  • QTc interval [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The investigators want to investigate whether the QTc complex gets wider during hypoglycaemia. This is in order to see whether long QTc could be the explanation behind sudden dearth in diabetes patients.

  • Skin temperature [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Skin temperature will be measured by thermography. The investigators want to see whether the skin can be used as a biomarker for hypoglycaemia.

  • Auditory evoked potentials [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The investigators what to see whether there is any difference in auditory evoked potentials (AEP) between aware and unaware diabetic patients. The subject will hear a common and a rare sound in a 4:1 ratio while the EEG is recorded. Afterwards the data is analyzed and the AEPs are addressed.

  • Cognitive function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The investigators want to address whether there are any differences in the cognitive function between aware and unaware patients. The cognitive function will be addressed by the use of cognitive function tests (CalCAP) and Stroops tests as well.


Enrollment: 23
Study Start Date: May 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Patients with hypoglycemia awareness
Patients who have symptoms when the blood sugar level is low
Procedure: Insulin clamp
Patients will be exposed to low bloodsugar
Other Names:
  • Insulin
  • clamp
Experimental: patients with hypoglycaemic unawareness.
Patients who do not feel any symptoms when the blood sugar levels are low
Procedure: Insulin clamp
Patients will be exposed to low bloodsugar
Other Names:
  • Insulin
  • clamp

Detailed Description:

Background:

Patients with type 1 diabetes are at risk of severe hypoglycaemia as a severe side effect to insulin therapy, in particular subjects who have lost warning of hypoglycaemia (hypoglycaemia unawareness). The episodes are associated with impaired quality of life and can lead to permanent brain damage and death.

During hypoglycaemia a low frequent activity can be seen with electroencephalography (EEG) as cognitive function declines. Repeated hypoglycaemic episodes result in down regulation of counter regulatory and symptomatic responses. It is not known whether a similar phenomenon is present for cerebral dysfunction as judged by EEG changes and cognitive function.

The purpose is to investigate the activity in the brain, the cognitive function, and the skin temperature when patients are exposed to repeated hypoglycaemia. The results will show whether the response to hypoglycaemia will change after repeated episodes.

The methods:

The investigators will recruit two groups of patients: Patients with hypoglycemia awareness and patients with hypoglycaemic unawareness.

The patients are exposed to hypoglycaemia on two concomitant days while the investigators record EEG and perform cognitive tests. Skin temperature is assessed by the use of thermography. If the patient has hypoglycaemic unawareness a 4 week period follows where the glycaemic control is loosened to avoid hypoglycaemia episodes and the patients is then exposed to hypoglycaemia again.

The prospect:

It is the investigators hope that results can contribute to improved understanding of hypoglycaemic EEG changes and skin temperature changes. This could be of potential benefit for patients with hypoglycaemic unawareness.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes
  • Age > 18 years
  • - Have had diabetes for more than 5 years
  • Negative pregnancy test
  • Caucasian
  • Signed written informed consent

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Epilepsy
  • Self-perceived impaired hearing
  • Use of antiepileptic medicine
  • Use of neuroleptics within the last 6 months
  • Use of benzodiazepines within the last month
  • Use of betablockers
  • Previous stroke or other disease in the brain
  • Cardiovascular disease
  • Alcohol-, drug- or medicine abuse
  • Previous allergic reaction to heparin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337362

Locations
Denmark
Hillerod Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
University of Southern Denmark
Rigshospitalet, Denmark
Hypo-Safe A/S
Investigators
Principal Investigator: Anne-Sophie Sejling, MD Hillerod Hospital
  More Information

No publications provided

Responsible Party: Anne-Sophie Sejling, MD, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01337362     History of Changes
Other Study ID Numbers: H-1-2011-024
Study First Received: March 30, 2011
Last Updated: October 15, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Hillerod Hospital, Denmark:
Diabetes
Hypoglycaemia
EEG
Thermography
Hypoglycaemia-associated autonomic failure
QTc interval
Hypoglycemic alarm device
Hormone response

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014