A Study to Assess Prevalence and Incidence of Long-term Complications of Type 1 Diabetes in a Tertiary Clinic in Pune.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Prevalence of Micro-vascular Complications.
研究概览
简要总结
Due to early diagnosis (<20yrs of age) of Type 1 Diabetes, patients face longer duration of disease and greater glycemic exposure which makes them more vulnerable towards chronic complications. The aim of this study is to investigate the prevalence and incidence of micro and macro-vascular, pulmonary complications and patterns of growth failure in approximately 500 Type 1 Diabetes patients enrolled at Diabetes Unit, King Edward Memorial Hospital Research Centre. Then follow up of 100 participants who are above 15 years of age at baseline will be done after 2 years to document incidence and progression of complications. This will contribute in assessing the public health burden of complications of Type 1 Diabetes.
Factors associated with prevalence of complications will be investigated. This risk factor analysis could aid in further modifying current prevention and treatment recommendations of these complications. Results of this study could modify current clinical practice.
详细描述
BACKGROUND & RATIONALE OF THE STUDY:
Type 1 Diabetes (T1D) is characterized by progressive destruction of insulin secreting pancreatic β-cells. The commonest mechanism involves autoimmunity to components of β-cells. As per International Diabetes Federation report 2013, India houses 67,700 children (<15yrs) with T1D. It also states an approximate figure of 10,900 newly diagnosed T1D children (<15yrs) per year. India accounts for highest number of children with T1D in South East Asian Region. Karnataka Diabetes Registry of T1D patients (1995 to 2008) reported an incidence of 3.8per 100,000 persons in India which is less when compared to Europe and other Western countries. Same study also reported that there is a huge gap between international standard of care and practice in India and that majority of T1D patients don't attain their glycemic targets.
Despite such unfavorable statistics, T1D does not receive adequate attention in terms of clinical and epidemiological research, achieving standards of practice and training of Medical practitioners. Many a times, it is also quoted as "Poor Cousin of Type 2 Diabetes".
A salient feature of T1D is its early onset and diagnosis (<20yrs of age) compared to type 2 diabetes. Consequently patients face longer duration of disease and greater glycemic exposure by the time they reach productive age and suffer chronic complications which are broadly classified into:
- Microvascular (retinopathy, neuropathy, and nephropathy) and
- Macrovascular [coronary artery disease (CAD), cerebrovascular disease (CVD), peripheral vascular disease (PVD)] .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes with a duration of diabetes more than 1 year.
- •Willingness to participate in the study and sign the consent form.
- •Age : all age groups
- •Gender : Both
排除标准
- •Other forms of diabetes like Type 2 Diabetes, Gestational Diabetes, Fibro Calculus Pancreatic Disease (FCPD), Mature Onset of Diabetes in Young (MODY) etc.
- •People with acute stages of diseases like pneumonia after being treated for the condition.
- •Advanced end stage conditions like Cancer etc.
- •Pregnant and lactating women
结局指标
主要结局
Prevalence of Micro-vascular Complications.
时间窗: Assessed in one day, approximately.
Following tests will be performed for micro-vascular complications : 1. RETINOPATHY: Retina scan images 2. NEPHROPATHY:Urine Albumin : Creatinine ratio), Serum Creatinine, estimated glomerular filtration rate (eGFR) 3. NEUROPATHY : Michigan Neuropathy Screening Instrument (MNSI) and Biothesiometer. 4. Pulmonary : Spirometry Prevalence will be reported as percentage i.e. number of cases divided by total number of study participants , multiplied by 100.
Prevalence of Macro-vascular Complications.
时间窗: Assessed in one day, approximately.
Following tests will be performed for macro-vascular complications : 1. Cardio-Vascular Disease :Blood pressure, Biochemical tests: Lipid Profile \[Triglycerides, Cholesterol (HDL, LDL, total)\] and ECG (Electrocardiogram \> 15 years of age) 2. Peripheral Vascular Disease : Ankle Brachial Index by Periscope Prevalence will be reported as percentage i.e. number of cases divided by total number of study participants , multiplied by 100.
Prevalence of Growth Complications.
时间窗: Assessed in one day, approximately.
Whole body Anthropometry and Pubertal staging by Tanner's method.
Incidence of Micro-vascular, Macro-Vascular and Pulmonary Complications.
时间窗: Assessed in one day, approximately.
Same tools as listed for primary objective 1 will be utilised for measuring incidence of these complications. - Incidence will be reported as number of new cases per year.
Progression of Micro-vascular, Macro-Vascular and Pulmonary Complications.
时间窗: Assessed in one day, approximately.
Same tools as listed for primary objective 1 will be utilised for measuring incidence of these complications. - Incidence will be reported as number of new cases per year.
次要结局
- Association of Risk factors with prevalence of complications.(All this data will be collected at the time of primary objective 1 i.e. in one day.)
研究者
Dr. Chittaranjan S Yajnik
Professor Dr.
King Edward Memorial Hospital