Objective Markers and New Indicators in Adrenal Insufficiency Disease (OMNI-AID Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Osteocalcin
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Osteocalcin
时间窗: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Assesses bone health of each group by comparing total osteocalcin and undercarboxylated osterocalcin
次要结局
- Blood pressure(Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.)
- Lipid profile (Total cholesterol, HDL, LDL and triglycerides)(Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.)
- High sensitivity CRP(Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.)
- Infection rates and severity(Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.)
- Wellbeing(Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.)
- Waist-Hip circumference(Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.)
- Heart Rate(Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.)
- Glucose(Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.)
- HbA1c(Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.)
- P1NP(Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.)
- NTX(Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.)