Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Glucose Infusion Rate by euglycemic-hyperinsulinic clamp
研究概览
简要总结
The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron overload patients.
详细描述
The main objective of this study is to evaluate in patients with HSD effects of treatment with phlebotomy rules with lifestyle and dietary rules versus lifestyle modifications alone on peripheral insulin resistance (assessed by hyperinsulinemic clamp).
Secondary objectives are:
-
to study in all patients with HSD the relationship between the amount of iron intrahepatic and degree of peripheral insulin resistance and liver before therapeutic intervention.
-
to study and compare the effects of phlebotomy treatment versus no treatment on:
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Plasma levels of adipocytokines,
-
Plasma concentrations of inflammatory markers and markers of insulin resistance,
-
The serum ferritin,
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The post-hepatic clearance of insulin,
-
The surface of the abdominal visceral fat and subcutaneous abdominal.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years
- •Ferritin between 450 and 1000 µg/L
- •Hepatic iron overload proved by MRI (CHF >36 µmol/g)
- •Body mass index > 25 kg/m²
- •Fasting glycemia <1,26 g/L
- •HbA1c < 6,5%
- •Signed written and informed consent
排除标准
- •Other causes of hyperferritinemia:
- •Inflammatory syndrome (CRP >10 mg/L) or inflammatory, immune or malignant diseases
- •Hyperferritinemia-cataract syndrome (familial cataract or personal history of cataract before 50 years old)
- •Low ceruloplasmin level
- •Porphyria (cutaneous signs)
- •Haemochromatosis established by the genotype (C282Y homozygous or C282Y/H63D coumpound heterozygous genotypes)
- •Contraindication of phlebotomy
- •Haemoglobin <13,5 g/dL (threshold established by the Etablissement Français du Sang)
- •Heart failure or coronary heart diseases
- •Hepatic failure, renal (GFR <50mL/min) or respiratory insufficiency (chronic dyspnea)
- •Poor venous system
- •Viral, immune, genetic, vascular, malignant or toxic chronic hepatic disease
- •Alcohol consumption more than 21 doses per week during 5 years or more
- •Type 1 or type 2 diabetes
- •Oral anti-diabetic, corticoids or immune suppressor drugs
- •Hepatic severe disease
- •Claustrophobia, having a pace-maker or intracerebral clips
- •Subjects deprived of their liberty by judicial or administrative decision, subjects that are not affiliated to social security or topics exclusion period of a previous study
研究组 & 干预措施
Phlebotomy
phlebotomy associated with dietary and lifestyle counseling
干预措施: dietary and lifestyle counseling (Behavioral)
Lifestyle counseling
dietary and lifestyle counseling
干预措施: dietary and lifestyle counseling (Behavioral)
Phlebotomy
phlebotomy associated with dietary and lifestyle counseling
干预措施: phlebotomy (Procedure)
结局指标
主要结局
Glucose Infusion Rate by euglycemic-hyperinsulinic clamp
时间窗: 6 months
次要结局
- HOMA-IR(6 months)
- Abdominal and sub-cutaneous fat surface (MRI)(6 months)
- hepatic parameters(6 months)
- lipid profile(at 6 months)
- SHBG(6 months)
- Hepatic iron overload (MRI)(6 months)
- iron parameters(at 6 months)
- Adipokins markers(6 months)
- inflammation markers(6 months)