Indian Phenotype Registry

Study Overview
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Brief Summary
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This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

Detailed Description
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This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB). This is a single visit cross sectional study however during site feasibility visit, probability of follow-up of these patients will be evaluated. If feasible protocol will be amended to continue data collection prospectively for appropriate duration

Official Title
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A Non-interventional Nationwide Registry to Identify Indian Phenotype Characteristics in Diabetes Mellitus Patients in India.

Conditions
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Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male or female patients with 18 years and above. Patients who provide written informed consent. Patients with previously diagnosed with Diabetes Mellitus HbA1C report available within past 3 months Exclusion Criteria- None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Diabetes Mellitus | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate total body fat content across various BMI categories in the study population | Bioelectrical impedance will be used to estimate how much % body fat in terms of weight compared to total body weight. Since it is a ratio (weight of fat/total body weight) so no unit is required. The ratio will be multiplied by 100 to get Fat percentage. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyse different characteristics of Diabetes Mellitus patient in study population | patient characteristics like age, gender | 1 day | 
| To correlate HbA1C level with various BMI categories | Weight in kilogram, height in meter will be combined to report BMI in kg/m2. then HbA1c in percentage and BMI in kg/m2 will be aggregated to get correlation | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, T2D