Prevalence and Incidence of Complications of Type One Diabetes in PUne At a Tertiary Care CentRE

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Prevalence of Micro-vascular Complications. — 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. — 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. — Assessed in one day, approximately.
  Whole body Anthropometry and Pubertal staging by Tanner's method.
• Incidence of Micro-vascular, Macro-Vascular and Pulmonary Complications. — 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. — 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.

Trial sites (1)