Effect of Hypoglycaemia on Social Cognition and Cardiac Conduction

NCT02347553 | Completed

• 1 other identifier: 152813
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

It is known that hypoglycaemia affects various domains of cognitive function. One aspect of cognitive function is 'social cognition', which is our ability to interpret facial expressions, gestures and speech. It is an approach to understanding human judgement and behaviour. There is anecdotal evidence for negative behavioural responses such as aggressiveness and argumentativeness during hypoglycaemia and while research has shown that hypoglycaemia can cause significant changes in mood, little information exists regarding its effect on social cognition. It is therefore not known whether hypoglycaemia affects this aspect of cognitive function but, if it did, it could explain why people with low blood sugar due to insulin treatment are often resistant to offers of help (for example, they may misinterpret a friendly gesture as being threatening). Knowledge of this effect of hypoglycaemia can be used to educate relatives and carers of people with diabetes who may suffer this problem. Hypoglycaemia is also known to have an effect on the electrical rhythm of the heart. This is thought to be secondary to adrenaline secretion during hypoglycaemia which provokes a fall in the blood level of potassium, a type of electrolyte. Other electrolyte imbalances are known to predispose to heart rhythm abnormalities or arrhythmias in other situations and it is not known if the levels of these other electrolytes are affected during hypoglycaemia. Using specific tests of social cognition and continuous electrocardiographic (ECG) monitoring, this study aims to find out whether social cognition is affected by an hour of hypoglycaemia and how hypoglycaemia affects blood electrolyte levels and the electrophysiology of the heart.

Conditions

Hypoglycaemia

Outcome Measures

Primary Outcomes (2)

• To measure change in social cognition scores during hypoglycaemia and compare that to scores obtained while euglycaemic.

  Each participant attends for 2 sessions; 1 where hypoglycaemia is induced during the experimental period and second where they are euglycaemic during the hour long experimental stage. Therefore, the time frame is one hour for measurement of social cognition.

  1 hour (experimental period is 1 hour) during each study session.

• To measure changes in electrolyte levels and QT interval on electrocardiography between hypoglycaemic and euglycaemic states

  Each participant attends for 2 study sessions. ECGs and electrolyte measurements are taken throughout the 4 hour study session each time.

  4 hours (ECGs and electrolyte measurements will be taken at various timepoints during both study sessions)

Interventions

This is not an interventional study OTHER

Participants will act as their own controls and will undergo the study procedure once in a hypoglycaemic state and once in a euglycaemic state. Therefore there is no intervention being studied as such.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

People with type 1 diabetes (i.e. insulin treated diabetes from the outset) will be recruited for this study.

You may qualify if:

• Type 1 diabetes (insulin-treated) for at least two years duration.
• HbA1c values between 42 mmol/mol and 97 mmol/mol within the preceding 6 months.
• Aged 18-40 years.
• Body mass index 18-35 kg/m2.

You may not qualify if:

• Participants will be excluded from the study if they meet any of the following criteria:
• Significant co-existent systemic disease or malignancy.
• Past history of severe hypoglycaemia.
• Past history of cardiovascular disease
• Past history of cerebral injury, seizure, chronic alcoholism or psychiatric disorder.
• Pregnancy. (Pregnancy testing will be carried out on all prospective female subjects).
• Impaired awareness of hypoglycaemia (defined as a score of 4 or more on the Gold scale)
• Use of drugs that affect heart rate and QT interval within the week before the study.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: January 27, 2015
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)