- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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)
연구 개요
상태
정황
상세 설명
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 .
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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London, 영국, W12 8RF
- 모병
- Imperial College Healthcare NHS Trust
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연락하다:
- Sirazum Choudhury, MBBS BSc
- 전화번호: 07555717544
- 이메일: steroids@imperial.ac.uk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Osteocalcin
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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P1NP
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 18HH4425
- 216757 (기타 식별자: IRAS ID)
- 18/LO/0069 (기타 식별자: REC reference number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
부신 기능 부전에 대한 임상 시험
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Umeå UniversityKarolinska University Hospital; Sahlgrenska University Hospital, Sweden; University Hospital... 그리고 다른 협력자들모병고립성 또는 복합성 구개열이 있는 소아의 Velopharyngeal Insufficiency스웨덴