NCT01045525已完成3 期
Prospective Randomized Study Comparing the Effect of Phlebotomy and Lifestyle and Diet Advices vs Lifestyle and Diet Advices Only on Glycemia in Patients With Dysmetabolic Liversiderosis
Rennes University Hospital10 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 试验地点
- 10
- 主要终点
- Fasting blood glycemia (T0 of Oral Glucose Tolerance Test)
研究概览
简要总结
Insulin resistance-associated hepatic iron overload (IR-HIO), also defined as dysmetabolic iron overload syndrome or dysmetabolic liversiderosis, is a common cause or iron overload in France, mainly in middle-age patients with increased serum ferritin levels associated with normal serum transferrin saturation, and normal serum iron concentration in the absence of other known cause of increased serum ferritin levels.
Treatment includes a combination of dietary measures and physical activity to correct metabolic disorders. Phlebotomies seem to be beneficial when serum ferritin level is high.
This study aims at comparing the effect of iron depletion (by phlebotomy) plus lifestyle and diet advices versus lifestyle and diet advices alone on blood glucose level and insulin sensitivity in subjects with IR-HIO in order to assess the benefits of phlebotomies on the reduction of risk of diabetes and cardiovascular associated complications.
详细描述
Non applicable
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18
- •Signed written informed consent
- •Ferritin ≥ 450 µg/L and ≤ 1500 µg/L
- •Hepatic iron overload proved by MRI or histological biochemical measurement (Iron hepatic concentration ≥ 50 μmol/g)
- •At least one of the following criteria :
- •Body mass index > 25 kg/m²
- •Systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90 mmHg or antihypertensive treatment
- •Abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women)
- •Fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment
- •Fasting HDL cholesterol < 1.03 mmol/L for men and < 1.29 mmol/L for women or HDL cholesterol-elevating treatment
- •Fasting blood glycemia ≥ 5.6 mmol/L
排除标准
- •Subjects deprived of their liberty by judicial or administrative decision
- •Pregnant women
- •Other causes of increased serum ferritin levels:
- •Inflammatory syndrome (CRP >10 mg/L) or inflammatory, immune or malignant diseases
- •Hyper-hemolysis
- •Alcohol consumption more than 210 g for men and 140 g for women per week within the year before inclusion
- •Haemochromatosis established by the C282Y homozygous genotype
- •Chronic hepatic cytolysis due to : viral infection (HBV, HCV), alcohol, hyperthyroid disease, celiac disease, drug or immune hepatitis
- •Increased serum ferritin levels - cataract syndrome (familial cataract or personal history of cataract before 50 years of age)
- •Low ceruloplasmin level
- •Porphyria (cutaneous signs)
- •Contraindication of phlebotomy
- •Haemoglobin <13 g/dL for men and <12g/dL for women (threshold established by the French Blood Agency)
- •Congestive heart failure or coronary heart disease
- •Hepatic failure (TP<60%), renal failure (GFR <50mL/min) or respiratory insufficiency (chronic dyspnea)
- •Poor venous system
- •Fasting blood glycemia > 7 mmol/L or type 1 or type 2 diabetes, treated or not
- •Use of drugs known to have anti-steatotic effects : metformin, thiazolidinedione
结局指标
主要结局
Fasting blood glycemia (T0 of Oral Glucose Tolerance Test)
时间窗: 12 months
次要结局
- Rate of abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women)(12 months)
- Rate of fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment(12 months)
- Rate of Body mass index > 25 kg/m²(12 months)
- Rate of fasting glycemia ≥ 5.6 mmol/L(12 months)
- Biological markers: CRP, hyaluronic acid, fibrometer(12 months)
- Rate of systolic blood pressure ≥ 130mmHg or diastolic blood pressure ≥ 85 mmHg or antihypertensive treatment(12 months)
- Rate of fasting HDL cholesterol < 1.03 mmol/L for men and < 1.29 mmol/L for women or HDL cholesterol-elevating treatment(12 months)
- HbA1c value(12 months)
- Quality of life estimated with SF36 form and tolerance to treatment(12 months)
- Insulinoresistance indexes calculated at T0 and T30 min of Oral Glucose Tolerance Test (OGTT)(12 months)
- myocardial deformation(12 months)
研究者
研究点 (10)
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