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Diabetes Type 1 and Fitness. (Diab1Fit)

2021年7月7日 更新者:Poznan University of Medical Sciences

Assessment of Physical Effort in People With Newly Diagnosed Type 1 Diabetes Mellitus and Its Impact on: Partial Clinical Remission, Insulin Resistance, HDL Cholesterol Function, Immune Function and Length of Life.

The Diab1Fit Study project aims to a multidirectional assessment of physical activity and its impact in people with type 1 diabetes (DM1). To the study are recruited people with newly diagnosed DM1, treated with intensive functional insulin therapy from the beginning of the disease. The study is planned to cover a minimum of 100 people with newly diagnosed DM1 and lead prospective observation of this group (for a minimum of 5-10 years). The investigators will evaluate the effect of VO2max in people with newly diagnosed DM1 on partial clinical remission. What is more the investigators also assess quantitative and qualitative changes of plasma lipoproteins, with particular emphasis on HDL metabolism, mechanism linking VO2max with management of DM1 (longevity proteins, miostatin, insulin resistance) and immune function.

研究概览

地位

招聘中

条件

详细说明

The Diab1Fit Study project aims to a multidirectional assessment of physical activity and its impact in people with type 1 diabetes (DM1). To the study are recruited people with newly diagnosed DM1, treated with intensive functional insulin therapy from the beginning of the disease. The study is planned to cover a minimum of 100 people with newly diagnosed DM1 and lead prospective observation of this group (for a minimum of 5-10 years). The investigators will evaluate the effect of VO2max in people with newly diagnosed DM1 on partial clinical remission. What is more the investigators also assess quantitative and qualitative changes of plasma lipoproteins, with particular emphasis on HDL metabolism, mechanism linking VO2max with management of DM1 (longevity proteins, miostatin, insulin resistance) and immune function.

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. Further continuous observation with follow-up every year and evaluation of final end-points after 5 and 10 years. In addition, the study group will be under constant monitoring of metabolic evaluation every three months in the Outpatient Clinic. An additional visit to assess VO2max will be scheduled between 3 and 12 months of diabetes. The investigators will use an ergospirometer (COSMED K5 System) during an exercise test carried out on a cycloergometer (progressive exercise test). Moreover, the investigators will monitor glucose levels during the exercise test - using a continuous glucose monitoring system using the FreeStyle Libre Flash Glucose Monitoring System (Abbott). A week before the exercise test, the investigators will borrow a Garmin watch that assesses the patient's daily activities

During each follow-up will be assessed parameters:

  1. The presence of partial clinical remission, according to Mortensen: HbA1c (%) + [4 x dawka insuliny (j/kg/d)] ≤ 9.
  2. Data on lifestyle (diet, exercise), family history and smoking.
  3. Anthropometric data:

    1. BMI (body mass index) = weight [kg]/(height [m])2
    2. Waist circumference
    3. WHR - waist to hip ratio
    4. daily insulin requirement (U/kg m.c./d),
    5. eGDR (estimated glucose disposal rate) = 24.31-12.22(WHR)-3.29(hypertension 0/1)-0.57( HbA1c [mg/kg/min])
    6. VAI (visceral adiposity index):

      For women = [Waist circumference/36.58+(1.89xBMI)]x(TG/0.81)x(1.52/HDL), For men = [Waist circumference /39.68+(1.88xBMI)]x(TG/1.03)x(1.31/HDL),

    7. body composition analysis
  4. Parameters of diabetes metabolic control

    1. Lipid profile
    2. Glycated hemoglobin level (HbA1c)
  5. Protein glycation end products Expected impact of the research project on the development of science, civilization and society: The study confirms the great importance of aerobic physical activity in the treatment of people with DM1 from the beginning of the diagnosis. The project aims to pay attention to the importance of physical activity among people with DM1 and to popularize this method of treatment. The obtained results will be used for the prospective observation of this group to assess the impact of physical effort on the development of chronic complications and will allow planning intervention studies in this population. The results of this study will help enrich knowledge about the body's ability to exercise among people with DM1 and show new intervention solutions. It may contribute to changing the recommendations of scientific societies. What is more knowledge about prolonging partial clinical remission and thereby reducing the risk of developing chronic complications will contribute to the introduction of new recommendations. Research on exercise in diabetes and longevity proteins will increase the length and quality of life of people with DM1.

研究类型

观察性的

注册 (预期的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Poznan、波兰、60-834
        • 招聘中
        • Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 35年 (成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

A minimum of 100 people with newly diagnosed type 1 diabetes hospitalized in the Department of Internal Medicine and Diabetology Poznan University of Medical Sciences.

描述

Inclusion Criteria:

  • Age 18-35 years,
  • New onset type 1 diabetes (confirmed by the presence of antibodies - antyGAD, ICA, IA2)
  • Treatment with intensive insulin therapy,
  • Written consent to participate in the study.

Exclusion Criteria:

  • Contraindications to the exercise test (including: recent myocardial infarction, unstable coronary artery disease, hypertrophic cardiomyopathy, serious arrhythmias, myocarditis, advanced systemic diseases, hyperthyroidism, recurrent anemia),
  • Mental disorders,
  • Co-morbidities with potential impact on physical performance (e.g. cancer, renal failure, liver failure, rheumatic diseases, COPD, asthma, anemia, hypothyroidism and hyperthyroidism),
  • Pregnancy.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:仅案例
  • 时间观点:预期

队列和干预

团体/队列
People with newly diagnosed diabetes mellitus type 1

People with newly diagnosed diabetes mellitus type 1 admitted to the Department of Internal Medicine and Diabetology.

Treated with intensive insulin therapy. Measurement of VO2max between 3 and 12 month after diagnosis. Further continuous observation with follow-up every year and evaluation of final end-points after 5 and 10 years.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
VO2max [ml/min/kg]
大体时间:1 year
VO2 max level evaluated during ergospirometry (COSMED K5)
1 year
Partial clinical remission time
大体时间:1 year
Presence [(4 x insulin dose (j/kg/d)] ≤ 9] and duration [time] of partial clinical remission
1 year

次要结果测量

结果测量
措施说明
大体时间
Triglicerydes concentriation in serum [mg/dl]
大体时间:Change from baseline in apolipoproteins' at 6 and 12 months
Changes in serum triglyceride levels
Change from baseline in apolipoproteins' at 6 and 12 months
LDL-C concentriation in serum [mg/dl]
大体时间:Change from baseline in apolipoproteins' at 6 and 12 months
Changes in serum LDL levels
Change from baseline in apolipoproteins' at 6 and 12 months
HDL-C concentriation in serum [mg/dl]
大体时间:Change from baseline in apolipoproteins' at 6 and 12 months
Changes in serum HDL levels
Change from baseline in apolipoproteins' at 6 and 12 months
Total Cholesterol concentriation in serum [mg/dl]
大体时间:Change from baseline in apolipoproteins' at 6 and 12 months
Changes in serum Total-CH levels
Change from baseline in apolipoproteins' at 6 and 12 months
Lipid tissue content [%]
大体时间:5 years
Evaluation of lipid tissue content prior to yearly visit.
5 years
A1c [%]
大体时间:5 years
Changes in serum A1c levels
5 years
Daily insulin requirement [u/kg/d]
大体时间:1 year
Sum of insulin units administered in the day prior to yearly visit.
1 year
Retinopathy
大体时间:5 years
Evaluation of retinopathy (ophthalmology assessment)
5 years
Neuropathy
大体时间:5 years
Evaluation of presence of neuropathy peripheral and autonomic (clinical examination, Visual Analog Score for pain and ProsciCard)
5 years
eGFR [ml/min/1,73m2]
大体时间:5 years
Assessment of glomerular filtration and renal filtration function
5 years
Creatynine [mg/dl]
大体时间:5 years
Assessment of renal function
5 years
Albumine to creatynine ratio ACR [mg/g]
大体时间:5 years
Assessment of renal function
5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年1月1日

初级完成 (预期的)

2022年12月31日

研究完成 (预期的)

2025年12月31日

研究注册日期

首次提交

2020年8月13日

首先提交符合 QC 标准的

2021年7月7日

首次发布 (实际的)

2021年7月20日

研究记录更新

最后更新发布 (实际的)

2021年7月20日

上次提交的符合 QC 标准的更新

2021年7月7日

最后验证

2021年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1050/19

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