Last reviewed · How we verify
NCT05515055
Does Relative Hypoglycaemia &/or Sleep Disturbance Contribute to the Lethargy Observed in Addison's Disease
trial testing Blood test in Addison Disease in 30 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | The Leeds Teaching Hospitals NHS Trust |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 7 April 2022 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Blood test — full drug profile →
Conditions studied
- Addison Disease — all drugs for Addison Disease →
Sponsor
The Leeds Teaching Hospitals NHS Trust
Who can join
18 and older, any sex, with Addison Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05515055
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05515055 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Leeds Teaching Hospitals NHS Trust
- Last refreshed: 17 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05515055.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing