Investigating causes of fatigue in Addison's disease
Does Relative Hypoglycaemia &/or Sleep Disturbance Contribute to the Lethargy Observed in Addison's Disease
This study looks at what might be causing fatigue in people with Addison's disease by checking their blood sugar levels and sleep patterns to see how these factors affect their overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Leeds Teaching Hospitals NHS Trust Academic / other |
| Locations | 1 site (Leeds) |
| Trial ID | NCT05515055 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the potential factors contributing to fatigue in patients with Addison's disease, focusing on blood sugar levels and sleep disturbances. Patients with primary adrenal insufficiency will undergo blood tests to assess their glucose levels and sleep patterns, as well as evaluate blood clotting as a possible mechanism for increased cardiovascular risks. The study seeks to understand how current glucocorticoid replacement therapies may impact these factors and contribute to the overall health status of individuals with Addison's disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with Addison's disease, with or without type 1 diabetes.
Not a fit: Patients with significant kidney disease, active cancer, or those unable to provide valid consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for fatigue in patients with Addison's disease.
How similar studies have performed: While there is limited research specifically targeting the fatigue in Addison's disease through this approach, studies on glucocorticoid replacement therapies have shown varying degrees of success in managing related symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged \>18 years 2. Known to have Addison's disease with or without type 1 diabetes 3. They are able to provide valid written consent Exclusion Criteria: 1. Having significant kidney disease 2. Having active cancer, other than localised/non-aggressive skin cancer 3. Being unable to provide valid written consent 4. Are deemed to be inappropriate to be enrolled in the study by senior members of the research team. This may involve things such as the patient being very frail and struggles to get to and from the hospital, would have problems using the equipment due to significant visual problems or problems with hands or are known to have significant problems with low blood sugars (in those with diabetes) and already take measures to prevent this. Other exclusions may be made at the discretion of the senior investigators
Where this trial is running
Leeds
- The Leeds Teaching Hospital NHS Trust — Leeds, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.