Objective Markers and New Indicators in AI Disease (OMNI-AID Study) (OMNI-AID)
13 août 2019 mis à jour par: Imperial College London
Objective Markers and New Indicators in Adrenal Insufficiency Disease (OMNI-AID Study)
This pilot study is designed to compare healthy volunteers with three groups of patients with adrenal insufficiency and a final group of patients receiving high dose steroids for anti-inflammatory purposes.
The study will collect data on all 5 groups with the intention of identifying any novel markers or immunological indicators which may be used clinically to gauge the adequacy of steroid replacement treatment in patients with adrenal insufficiency.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Description détaillée
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 .
Type d'étude
Observationnel
Inscription (Anticipé)
100
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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London, Royaume-Uni, W12 8RF
- Recrutement
- Imperial College Healthcare NHS Trust
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Contact:
- Sirazum Choudhury, MBBS BSc
- Numéro de téléphone: 07555717544
- E-mail: steroids@imperial.ac.uk
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Osteocalcin
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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P1NP
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2018
Achèvement primaire (Anticipé)
2 avril 2021
Achèvement de l'étude (Anticipé)
2 avril 2021
Dates d'inscription aux études
Première soumission
31 juillet 2018
Première soumission répondant aux critères de contrôle qualité
31 juillet 2018
Première publication (Réel)
6 août 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 août 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 août 2019
Dernière vérification
1 août 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 18HH4425
- 216757 (Autre identifiant: IRAS ID)
- 18/LO/0069 (Autre identifiant: REC reference number)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
There are currently no plans to share individual data with other researchers
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .