Different physiological states (e.g. phases of menstrual cycle e.g. follicular, pre-ovulatory, luteal phase) and endocrine conditions (e.g. Cushing’s syndrome, Addison’s disease, Acromegaly, Hypothalamic Amenorrhoea, Polycystic Ovary Syndrome). Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged =18 years old 2. Either no current medical condition OR a current medical condition that can be diagnosed or monitored using biomarkers
Exclusion criteria
Exclusion criteria: 1. History of medical, psychological or other conditions, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study results to make them no longer useful or could potentially result in harm to the participant. 2. History of blood donation within the past 3 months, or the intention to do so within 3 months of completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Biomarker levels in biological fluid(s) measured using the aptamer device via intermittent sampling compared with biomarkers measured in blood using standard laboratory assay methods, both for up to 720 minutes during Visit 1 and up to 5 other study visits in healthy volunteers and patients with a medical condition that can be diagnosed or monitored using biomarkers. 2. Production of normative ranges for biomarkers measured using the novel aptamer device (at different times of the day, e.g. 0800-1000, 1200 and 1700) in healthy volunteers in different physiological states (e.g. the follicular, pre-ovulatory and luteal phases of the menstrual cycle) and people with endocrine conditions (e.g. Cushing’s syndrome, Addison’s disease, Acromegaly, hypothalamic amenorrhoea, polycystic ovary syndrome). | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom