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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Partial clinical remission time
研究概览
简要总结
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.
详细描述
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:
-
The presence of partial clinical remission, according to Mortensen: HbA1c (%) + [4 x dawka insuliny (j/kg/d)] ≤ 9.
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Data on lifestyle (diet, exercise), family history and smoking.
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Anthropometric data:
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BMI (body mass index) = weight [kg]/(height [m])2
-
Waist circumference
-
WHR - waist to hip ratio
-
daily insulin requirement (U/kg m.c./d),
-
eGDR (estimated glucose disposal rate) = 24.31-12.22(WHR)-3.29(hypertension 0/1)-0.57( HbA1c [mg/kg/min])
-
VAI (visceral adiposity index):
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
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Partial clinical remission time
时间窗: 1 year
Presence \[(4 x insulin dose (j/kg/d)\] ≤ 9\] and duration \[time\] of partial clinical remission
VO2max [ml/min/kg]
时间窗: 1 year
VO2 max level evaluated during ergospirometry (COSMED K5)
次要结局
- Daily insulin requirement [u/kg/d](1 year)
- Retinopathy(5 years)
- LDL-C concentriation in serum [mg/dl](Change from baseline in apolipoproteins' at 6 and 12 months)
- HDL-C concentriation in serum [mg/dl](Change from baseline in apolipoproteins' at 6 and 12 months)
- eGFR [ml/min/1,73m2](5 years)
- A1c [%](5 years)
- Creatynine [mg/dl](5 years)
- Albumine to creatynine ratio ACR [mg/g](5 years)
- Triglicerydes concentriation in serum [mg/dl](Change from baseline in apolipoproteins' at 6 and 12 months)
- Total Cholesterol concentriation in serum [mg/dl](Change from baseline in apolipoproteins' at 6 and 12 months)
- Lipid tissue content [%](5 years)
- Neuropathy(5 years)