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Completed

NCT Number: NCT01337362

Recurrent Hypoglycaemia in Type 1 Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hillerod Hospital

Hillerød, 3400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin clamp

Procedure

Patients will be exposed to low bloodsugar

Other names: Insulin, clamp

Primary outcomes

  1. EEG

    Time frame: 2 years

    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 outcomes

  1. QTc interval

    Time frame: 2 years

    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.

  2. Skin temperature

    Time frame: 2 years

    Skin temperature will be measured by thermography. The investigators want to see whether the skin can be used as a biomarker for hypoglycaemia.

  3. Auditory evoked potentials

    Time frame: 2 years

    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.

  4. Cognitive function

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Hillerod Hospital, Denmark

Other

Collaborators

  • Rigshospitalet, Denmark
  • UNEEG Medical A/S
  • University of Southern Denmark

Registry information

Official study title

Recurrent Hypoglycaemia in Type 1 Diabetes: Effects on Cognitive Function, Cerebral Electrical Activity, and Skin Temperature

Acronym: HypoNeuro

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2011
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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