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Does Relative Hypoglycaemia &/or Sleep Disturbance Contribute to the Lethargy Observed in Addison's Disease

NCT05515055 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-07-17

No results posted yet for this study

Summary

Addison's disease is a condition that leads to a reduction in production of steroid hormones from the adrenal glands. These hormones, particularly cortisol have many important roles in the body, one of which is increasing blood sugar. These steroids will be replaced with tablets but fails to mimic the normal increase in natural cortisol levels which increase from around 2am in the early morning. Furthermore, steroid tablets have been associated with stopping patients from going to sleep.

Patients with Addison's disease on treatment still complain of excessive fatigue and have an increased risk of death from blood vessel diseases. Some case reports have shown some patients with Addison's disease to have low blood sugars overnight.

To investigate the possible causes of fatigue in Addison's disease by examining sugar levels and sleep patterns of our patients. Blood clotting will also be looked at as a potential mechanism for the unexplained increase in blood vessel diseases. To examine sugar levels a small probe will be attached to the upper arm which the patients will wear for 14 days to measure blood glucose very regularly and is painless. Additionally the patients will wear a watch that monitors sleep, movement, and light. A single blood sample will be taken to measure vascular risk markers and how the blood clots.

After wearing the monitors the subjects will complete questionnaires assessing quality of life. Healthy individuals will be recruited to undergo the same monitoring to act as a control group.

The data data obtained between Addison's disease and healthy subjects will be compared.

The scores from the questionnaires will be compared to the glucose and sleep readings to ascertain if there is a link between low blood sugars or sleep disturbance and their quality of life to determine if any physical abnormalities translate in to the poor quality of life.

Conditions

  • Addison Disease

Interventions

OTHER

Blood test

1 blood sample extra to standard of care is taken

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05515055 on ClinicalTrials.gov