- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03615859
Objective Markers and New Indicators in AI Disease (OMNI-AID Study) (OMNI-AID)
Objective Markers and New Indicators in Adrenal Insufficiency Disease (OMNI-AID Study)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Glucocorticoid replacement in adrenal insufficiency poses a significant challenge. If given too much, patients risk long term complications including diabetes, osteoporosis and cardiovascular disease. If, however they are given too little, patients can feel tired, unwell and may collapse as there is insufficient steroid hormone to cope with stress.
Currently there is no single objective marker or outcome that can be measured to ascertain whether a patient is receiving optimum glucocorticoid replacement therapy. This study will investigate a selection of markers to examine whether they can be used to as indicators to gauge the adequacy of therapy. Finding an appropriate marker could unlock better care and outcomes for our patients with adrenal insufficiency .
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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London, Regno Unito, W12 8RF
- Reclutamento
- Imperial College Healthcare NHS Trust
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Contatto:
- Sirazum Choudhury, MBBS BSc
- Numero di telefono: 07555717544
- Email: steroids@imperial.ac.uk
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Individuals with either primary or secondary adrenal insufficiency who are currently receiving glucocorticoid replacement therapy with hydrocortisone or prednisolone.
Healthy volunteers will serve as positive controls.
Patients on high (anti-inflammatory) doses of steroids for any other medical condition will serve as positive controls.
Descrizione
Inclusion Criteria:
- Aged 18 - 85 years
- Male or female
- Participants who are otherwise healthy enough to participate, as determined by pre-study medical history and physical examination
Patient groups only:
- Diagnosed with AI for over 6 months according to standard diagnostic criteria or with a medical condition requiring acute high dose steroid therapy for anti-inflammatory purposes
- If diagnosed with AI, established on stable HC replacement or prednisolone replacement, dose not altered for at least 3 months
- Established on a stable dose of Fludrocortisone, if taking, dose not altered for at least 3 months
- Participants taking other hormone replacements (e.g. levothyroxine, testosterone or growth hormone in secondary adrenal insufficiency) are accepted providing that their replacement doses have not altered for at least 3 months
- Participants who are able and willing to give written informed consent to participate in the study.
Exclusion Criteria:
- Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.
- Unable to give informed consent.
- Excessive caffeine intake above 500 mg per day.
- Taking supplements or herbal medications that the participant is unwilling or unable to stop prior to and during the study period e.g. St John's Wort (may decrease prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).
- Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the participant is unwilling or unable to stop prior to and during the study period e.g. phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone, aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.
- Pregnancy, taking the oral contraceptive pill, or oral oestrogen replacement therapy due to the effects on cortisol binding globulin levels and determination of prednisolone levels. Transdermal oestrogen replacement is permitted. Females of child-bearing age will be asked to provide a urine sample for a pregnancy test at each visit.
- Diagnosis of growth hormone deficiency, untreated
- History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Healthy volunteers
Healthy volunteers whose data represents a negative control
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Prednisolone replacement group
Participants with adrenal insufficiency who are treated with replacement doses of prednisolone
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Hydrocortisone replacement group
Participants with adrenal insufficiency who are treated with replacement doses of hydrocortisone
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New adrenal insufficiency group
Participants who have recently been given a new diagnosis of adrenal insufficiency
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High dose steroids groups
Participants who are treated with high dose steroids for management of any medical condition to serve as a positive control
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Osteocalcin
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Assesses bone health of each group by comparing total osteocalcin and undercarboxylated osterocalcin
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
P1NP
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Assesses bone health of each group by comparing P1NP
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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NTX
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Assesses bone health of each group by comparing NTX
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Heart Rate
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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recording observations- heart rate
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Blood pressure
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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recording observations- blood pressure
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Waist-Hip circumference
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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recording observations- Waist-Hip circumference ratios
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Lipid profile (Total cholesterol, HDL, LDL and triglycerides)
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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measuring biochemical indicators of cardiovascular risk: total cholesterol, HDL, LDL and triglycerides
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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High sensitivity CRP
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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measuring biochemical indicators of cardiovascular risk: high sensitivity CRP
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Glucose
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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measuring glucose
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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HbA1c
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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measuring HbA1c
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Infection rates and severity
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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assessed by completion of the German National Cohort Questionnaire (GNCQ), questionnaires will cover socio-economic and socio-demographic factors, medical history, use of medications and health care, lifestyle factors, and questions related to environmental and occupational factors
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Wellbeing
Lasso di tempo: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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the short form health survey-36 (SF-36)
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Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
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Collaboratori e investigatori
Sponsor
Collaboratori
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 18HH4425
- 216757 (Altro identificatore: IRAS ID)
- 18/LO/0069 (Altro identificatore: REC reference number)
Piano per i dati dei singoli partecipanti (IPD)
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