Indian Phenotype Registry (IP Registry)
|ClinicalTrials.gov Identifier: NCT03363594|
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : March 15, 2018
|Condition or disease|
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
|Study Type :||Observational|
|Estimated Enrollment :||50000 participants|
|Official Title:||A Non-interventional Nationwide Registry to Identify Indian Phenotype Characteristics in Diabetes Mellitus Patients in India.|
|Actual Study Start Date :||December 11, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
- To evaluate total body fat content across various BMI categories in the study population [ Time Frame: 1 day ]
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.
- To analyse different characteristics of Diabetes Mellitus patient in study population [ Time Frame: 1 day ]patient characteristics like age, gender
- To correlate HbA1C level with various BMI categories [ Time Frame: 1 day ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363594
|Contact: AstraZeneca Clinical Study Information Centeremail@example.com|
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