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NCT Number: NCT03363594

Indian Phenotype Registry

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).

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Key information

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Guntur, Andhra Pradesh, India

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: IP Registry

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2017
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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