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Indian Phenotype Registry (IP Registry)

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ClinicalTrials.gov Identifier: NCT03363594
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

November 20, 2017
December 6, 2017
May 10, 2018
December 11, 2017
December 31, 2018   (Final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT03363594 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Indian Phenotype Registry
A Non-interventional Nationwide Registry to Identify Indian Phenotype Characteristics in Diabetes Mellitus Patients in India.
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 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

Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Not Provided
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Non-Probability Sample
Diabetes Mellitus patients
Diabetes Mellitus
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1
Diabetes Mellitus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50000
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. Male or female patients with 18 years and above.
  2. Patients who provide written informed consent.
  3. Patients with previously diagnosed with Diabetes Mellitus
  4. HbA1C report available within past 3 months

Exclusion Criteria- None

Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
India
 
 
NCT03363594
D1843R00282
Not Provided
Not Provided
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AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
May 2018