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临床试验/NCT01572259
NCT01572259Unknown3 期

Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
40
试验地点
1
主要终点
To measure of Growth hormone

研究概览

简要总结

Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality in insulin resistant states. The typical dyslipidemia that is associated with insulin resistance, which includes a postprandial increase of triglyceride-rich lipoproteins (TRL) with excess of intestinal triglyceride-rich-lipoprotein-apoB-48 (TRL-apoB-48), is felt to play an important role in the accelerated ASCD. Recently, intestinal TRL-apoB-48 overproduction appeared as a newly recognized component of insulin resistance. There is only a limited amount of information in the literature regarding the factors and the mechanisms modulating the metabolism of intestinal TRL-apoB-48 in the setting of insulin resistance

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
None

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

入选标准

  • Male or feminine
  • age from 18 to 70 years
  • deficit in growth hormone informed by a peak lower than 10 mUI / l in answer to a test of hypoglycemia (or another test of stimulation if the hypoglycemia insulinique is dissuaded) (cf. attached the RCP of various growth hormone used at the adult)
  • centre (treatments optimized previously will be maintained during all the duration of the study) thyréotrope, corticotrope and gonadotrope substituted well for at least 6 months
  • IMC(CEREBRAL-MOTOR HANDICAPPED) < 30 kg / m2
  • fasting blood glucose < 1,26 g/L
  • clearance of the creatinine > 60 ml / min

排除标准

  • Nobody particularly protected: incapable major and private person of freedom, person hospitalized for another pathology; · nobody mastering the reading of the French language
  • carrier patients of a tumor in service
  • pregnant woman

研究组 & 干预措施

interruption of the growth hormone treatment.

Experimental

干预措施: interruption of the traitment with growth hormone (Other)

Patients traited by grouth hormone

Experimental

干预措施: Growth Hormone (Drug)

结局指标

主要结局

To measure of Growth hormone

时间窗: 3 YEARS

that growth hormone modulates directly, or indirectly by the changes of insulin sensitivity

次要结局

  • to measure the adipocytokines levels (leptin, adiponectin, resistin) the metabolism (production and/or clearance) of the intestinal TRL(3 YEARS)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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