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

NCT05515055 | Unknown DMC

• 1 other identifier: ED22/147142
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of low blood sugars events overnight in patients with Addison's disease will be measured to determine if there is an increased number of low blood sugars events overnight in patients who suffer from Addison's disease.

  3 months

Secondary Outcomes (4)

• Is the mean blood sugars of patient's with Addison's disease lower than in healthy subjects and Is there greater variation in blood sugar in patients with Addison's disease?

  3 months

• Does having low blood sugars contribute to the impaired quality of life of patients with Addison's disease and does sleep disturbance contribute to the impaired quality of life of patients with Addison's disease?

  3 months

• To examine vascular risk factors, particularly abnormalities of clot formation and degradation, that may contribute to the reported excess mortality of patients with PAI.

  3 months

• Does physiological steroid replacement lead to disturbance of normal sleep patterns?

  3 months

Interventions

Blood test OTHER

1 blood sample extra to standard of care is taken

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Importantly healthy people will be recruited who do not suffer from either Addison's disease or diabetes and will undergo the same process as detailed above to act as a healthy control group. The same exclusion criteria will apply to these participants. There are a number of people (termed controls) who have helped the research team with previous studies who will be invited to participate. These controls will be matched to a participant who suffers from Addison's disease/Addison's disease and type 1 diabetes by age, sex and a measure of height and weight termed body mass index (BMI) It is important that the two groups contain a similar population (other than suffering from Addison's disease) so that results are robust and bias is avoided.

You may qualify if:

• Aged \>18 years
• Known to have Addison's disease with or without type 1 diabetes
• They are able to provide valid written consent

You may not qualify if:

• Having significant kidney disease
• Having active cancer, other than localised/non-aggressive skin cancer
• Being unable to provide valid written consent

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

The Leeds Teaching Hospital NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Addison Disease

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Adrenal Insufficiency; Adrenal Gland Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: August 25, 2022
• Study Start: April 7, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)