A Double Blind Randomised Placebo-controlled Trial to Assess the Effect of a Single Administration of Ferric Carboxymaltose of 1000 mg Iron on Glucose Homeostasis, in Iron-deficient Non-anaemic Women of Childbearing Age.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation.
研究概览
简要总结
In this study the investigators aim at addressing potential relationships between iron stores and glucose homeostasis. Iron (i.e. Ferric Carboxymaltose) will be perfused to pre-menopausal, iron-deficient non-anaemic women suffering from a chronic fatigue syndrome and parameters related to glucose homeostasis, parameters related to metabolic syndrome and inflammation will be measured before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
To ensure that patients are unaware of the study drug they are receiving, the infusion pouch will be prepared in a separate room by members of the pharmacy unit and opaque bags will cover the infusion kits and infusions will be done via dark coloured infusion sets. Finally, a curtain will be used to shield the injection site from the patient's view.
To ensure that Outcomes Assessors are unaware of the study drug the patient is receiving, a seperate team of care providers will supervise the infusion of the investigation product and collect and/or manage adverse events (AEs) and serious adverse events (SAEs). The Outcome Assessor will not have access to participant related data during the randomised part of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women.
- •Negative pregnancy test.
- •Adequate contraception during the study period and for 1 month following study completion.
- •Overt or relative iron deficiency at screening defined as follows:
- •Serum ferritin <50 ng/mL AND transferrin saturation <20%, OR Serum ferritin <30 ng/mL.
- •Serum C-reactive protein: <5 mg/L if not on oral contraception, OR <20 mg/L if use of oral contraception
- •Intolerance to oral iron formulations, or lack of efficacy of oral iron formulations.
- •Minimum total score of 5 on the Visual analogic scale of fatigue.
- •Normal levels of vitamin B12 and folic acid at screening.
- •Availability and willingness to complete all study visits and procedures per protocol.
- •Ability to sign an informed consent.
排除标准
- •Age <18 years.
- •Menopause (defined as an amenorrhea of at least 12 months).
- •Irregularly menstruating women (menstrual cycle outside a range of 24-38 days in duration) or experiencing overt metrorrhagia (simple spotting not being an exclusion criteria).
- •Body mass index <18.5 kg/m2 or >30 kg/m
- •Diabetes, defined as subjects with HbA1c ≥ 6.5 % and/or with fasting blood glucose levels ≥ 7 mmol/l and/or with a history of diabetes and/or by the use of anti-diabetic drugs.
- •Hb level <117 g/L or known haemoglobinopathy or haemochromatosis.
- •Blood transfusion within the last 12 weeks.
- •Intake of iron preparations 4 weeks prior to screening.
- •Known hypersensitivity to FCM or to any other iron preparation.
- •Suspicion of major depressive disorder based on Patient Health Questionnaire.
- •Known chronic inflammatory disease, including human immunodeficiency virus, hepatitis B or hepatitis C virus infection.
- •Active malignancy.
- •Decreased renal function (estimated glomerular filtration rate using the CKD-EPI equation<60 ml/min/1.73m2).
- •Liver dysfunction (aspartate aminotransferase and alanine aminotransferase > 3-fold upper limit).
- •Angina (Class IV).
- •Documented sleep apnoea.
- •Important recent weight loss (>10% within the past month).
- •Thyroid dysfunction (thyroid stimulating hormone >4 µU/mL).
- •Reported weekly alcohol consumption > 14 standard drinks.
- •Drug abuse (any drug consumption reported in the past 12 months).
研究组 & 干预措施
Ferric carboxymaltose arm
Ferric carboxymaltose (FCM), 1000 mg iron element will be administered once by drip infusion (Intravenous route). FCM will be diluted in 250 mL of a commercially available sterile 0.9% sodium chloride solution prior to administration. Infusion time will be 15 minutes.
干预措施: Ferric Carboxymaltose (Drug)
Placebo arm
A commercially available sterile, 250 mL, 0.9% sodium chloride solution will be administered by drip infusion (Intravenous route). Infusion time will be 15 minutes.
At the end of the randomised part of the study, participants initially randomised to the placebo group will be included in a non-blinded open-label extension part and receive a FCM 1000 mg injection.
干预措施: 0.9% sodium chloride solution (Drug)
结局指标
主要结局
Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation.
时间窗: at 28 days of the injection of the Investigation Product
two-step hyperglycaemic clamp investigation
次要结局
- Change from baseline in interleukin-1beta levels at 28 days(at 28 days of the injection of the Investigation Product)
- Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 14 days(at 14 days of the injection of the Investigation Product)
- Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 28 days(at 28 days of the injection of the Investigation Product)
- Change from baseline in interleukin-6 (IL-6) levels at 14 days(at 14 days of the injection of the Investigation Product)
- Change from baseline in interleukin-6 (IL-6) levels at 28 days(at 28 days of the injection of the Investigation Product)
- Change from baseline in adiponectin levels at 14 days(at 14 days of the injection of the Investigation Product)
- Change from baseline in adiponectin levels at 28 days(at 28 days of the injection of the Investigation Product)
- Change from baseline in interleukin-1beta levels at 14 days(at 14 days of the injection of the Investigation Product)
- Change from baseline in blood pressure levels at 14 days(at 14 days of the injection of the Investigation Product)
- Change from baseline in blood pressure levels at 28 days(at 28 days of the injection of the Investigation Product)
- Change from baseline in the plasma lipid profile level at 14 days(at 14 days of the injection of the Investigation Product)
- Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 14 days(at 14 days of the injection of the Investigation Product)
- Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 28 days(at 28 days of the injection of the Investigation Product)
- Change from baseline in the plasma lipid profile level at 28 days(at 28 days of the injection of the Investigation Product)
研究者
Prof Gérard WAEBER
Head of the Department of Medicine
University of Lausanne