None listed
Conditions
Brief summary
The purpose of the study is to investigate possible mechanisms by which glucocorticoids raise blood pressure. The hypothesis is that glucocorticoids raise blood pressure by suppression of nitric oxide activity. The study tests this hypothesis by examining whether oral administration of isosorbide mononitrate, which is a nitric oxide donor, changes blood pressure in patients whose blood pressure has gone up after 5 days of treatment with oral hydrocortisone.
Interventions
Healthy human subjects will be treated with oral hydrocortisone 200mg per day for 5 days. Blood pressure and metabolic parameters will be measured regularly. On the last day of hydrocortisone treatment, a single dose of oral isosorbide mononitrate will be given and the effect of this dose on blood pressure will be measured.Hydrocortisone will be administered at a dose of 50mg four times per day to provide a total daily dose of 200mg hydrocortisone per day. Isosorbide mononitrate will be adminis
Healthy human subjects will be treated with oral hydrocortisone 200mg per day for 5 days. Blood pressure and metabolic parameters will be measured regularly. On the last day of hydrocortisone treatment, a single dose of oral isosorbide mononitrate will be given and the effect of this dose on blood pressure will be measured.Hydrocortisone will be administered at a dose of 50mg four times per day to provide a total daily dose of 200mg hydrocortisone per day. Isosorbide mononitrate will be administered as a single oral dose of 60mg. It will be administered on the morning to the 5th hydrocortisone treatment day prior to the 17th dose of oral hydrocortisone (out of a total of 20 doses of hydrocortisone administered over the whole treatment phase). Oral hydrocortisone administration at a dose of 200mg per day is expected to result in a number of metabolic changes including weight gain, elevation of white cell count, plasma glucose and cortisol concentrations, and reductions in plasma potassium and haematocrit. Compliance with therapy will be assessed by a pill count on each attendance at the clinical study centre, Additionally at the beginning and end of each treatment phase measurement of body weight, plasma electrolytes, glucose and cortisol concentrations and measurement of haematocrit and white cell count will be undertaken, There will be a minimum two week wash out period between each treatment phase.
Sponsors
Dr John Kelly
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy male volunteers on no regular medications
Exclusion criteria
Prior history of high blood pressure or diabetes. History of allergy to oral compounds in the study protocol. Any comorbid medical conditions that may be exacerbated by oral hydrocortisone e,g gastro-oesophageal reflux, anxienty, sleep disorder, mood disorder. Requirment for any regular medication.
Outcome results
None listed