The Pulses Study

Not Applicable

Completed

• Conditions: Subtopic: Metabolic & Endocrine; Disease: Metabolic & Endocrine; Topic: Metabolic & Endocrine; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN67193733
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

2023 Results article in https://doi.org/10.1111/joim.13721 (added 20/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-03
• Study Completion: 2022-08-14
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Male and female patients with confirmed Addison’s disease and CAH
2. Aged 18 to 64 years
3. Females of child bearing potential must be using a highly effective method of contraception / birth control as defined in ICH (M3) if sexually active
4. Right handed
5. Able to give informed consent

Exclusion Criteria

1. Any significant current cerebral, cardiovascular, respiratory, hepatobiliary, pancreatic disease, renal dysfunction, gastrointestinal emptying or motility disturbances.
2. No current treatment or within the last 3 months of another underlying disease that could necessitate treatment with glucocorticoids
3. Taking of medications that interfere with cortisol metabolism (antiepileptics, St Johns wart, rifampicin)
4. Diagnosis of Addison’s disease less than 6 months ago
5. Pregnant or lactating women
6. Greater than 21 units of alcohol per week
7. Taking of any investigational drug within the past two months
8. Known allergy to any of the study medications and /or materials used in the pump
9. Needle phobia
10. Contraindication to fMRI scan i.e. metal implant/shrapnel
11. Claustrophobia
12. Left handed/significant ambidexterity
13. Dyslexia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 24/02/2021: <br><br>Cognitive and emotional outcome of the P1 vital Emotional test battery at week 6.<br><br>_____<br><br>Previous primary outcome measure:<br><br>Physiological cortisol profiles with adequate suppression of ACTH in all patients and 17-OHP in CAH patients using subcutaneous pulsatile hydrocortisone replacement. Timepoint(s): baseline and 6 weeks