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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 : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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).

Condition or disease
Diabetes Mellitus

Detailed Description:

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
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Group/Cohort
1
Diabetes Mellitus



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. To analyse different characteristics of Diabetes Mellitus patient in study population [ Time Frame: 1 day ]
    patient characteristics like age, gender

  2. 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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetes Mellitus patients
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363594


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03363594     History of Changes
Other Study ID Numbers: D1843R00282
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

Keywords provided by AstraZeneca:
Diabetes, T2D

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases