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临床试验/NCT02306005
NCT02306005招募中不适用

Insulin Therapy and Quantitive and Qualitive Changes of Plasma Lipoproteins in Patients With Newly Diagnosed Type 1 Diabetes.

Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Changes in lipoproteins' metabolism

研究概览

简要总结

The aim of the study is to evaluate the effect of insulin therapy in patients with newly diagnosed type 1 diabetes on quantitative and qualitative changes of plasma lipoproteins, with particular emphasis on HDL metabolism, and analysis of the factors determining the effect of insulin therapy on lipid profile.The study is planned to cover a minimum of 100 people with newly diagnosed type 1 diabetes and lead prospective observation of this group (for a minimum of 5-10 years). Patients will be assessed: during the first hospitalization in the moment of diagnosis (prior to introduction of insulin treatment), after 3 weeks, after 6 months and after 12 months of insulin therapy. Further observations planned in the annual intervals. In addition, the study group will be under constant monitoring of metabolic evaluation every three months in the Outpatient Clinic.

During each follow-up will be assessed parameters evaluating the metabolism of plasma lipoprotein fractions and subfractions of HDL:

  1. The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E

  2. Electrophoresis of plasma lipoproteins

  3. Electrophoresis of HDL

  4. The activity of enzymes: acyltransferase lecithin: cholesterol (LCAT) and plasma lipoprotein lipase Moreover, evaluation of factors which may potentially modify the relation between insulin therapy and lipoproteins will be assessed

  5. Anthropometric data and markers of insulin resistance (such as BMI, waist-hip ratio, the estimated rate of glucose distribution, VAI index, body fat, blood pressure),

  6. Metabolic management of diabetes,,

  7. Protein glycation end products

  8. The concentration of plasma adipokines.

Expected impact of the research project on the development of science, civilization and society The obtained results allow to assess the impact of exogenous insulin on quantitative and qualitative changes and metabolism of lipoproteins in the serum of patients with type 1 diabetes. Understanding the etiopathogenesis of this phenomenon and the factors affecting it seem to be very important in the treatment of patients with type 1 diabetes, where insulin is the treatment of choice and dosage adjustment appears to be extremely important. Remains unknown whether the changes in the lipoprotein profile result from the beginning of insulin therapy or other factors influence it. Selecting a group of patients with less favorable lipoprotein profile may allow better metabolic control, and thus will affect the quality and length of life of our patients. These studies will assess the impact of our therapeutic actions on the diagnosis of the disease on long-term consequences, such as the development of chronic complications.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • New onset type 1 diabetes and treatment with insulin.
  • Written consent to participate in the study.
  • There are no other medical conditions, and with no other additional drugs beyond insulin

排除标准

  • any other medical conditions, and any other additional drugs beyond insulin

结局指标

主要结局

Changes in lipoproteins' metabolism

时间窗: Change from Baseline in lipoproteins' metabolism at 6 and 12 months

Evaluation of HDL levels, subfractions and enzymes connected with HDL metabolism (LCAT, lipoprotein lipase)

Factors influencing relationship between insulin treatment and lipoproteins

时间窗: 1 year

Metabolic control, presence of remission, insulin resistance, adipokines, daily insulin requirement

次要结局

  • Changes in apolipoproteins(Change from baseline in apolipoproteins' at 6 and 12 months)
  • Presence of insulin resistance(1 year)
  • Development of Retinopathy(1 year)
  • Development of Neuropathy(1 year)
  • Development of Diabetic kidney disease(1 year)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandra Uruska

PhD, MD

Poznan University of Medical Sciences

研究点 (1)

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