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Indian Phenotype Registry (IP Registry)

12 de junio de 2020 actualizado por: AstraZeneca

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).

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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

Tipo de estudio

De observación

Inscripción (Actual)

40000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • India
      • Chandigarh, India, D1843R00282
        • Research Site
      • Goa, India, D1843R00282
        • Research Site
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Kakinada, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Madanapalle, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Nellore, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Rajahmundry, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Vijaywada, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Visakhapatnam, Andhra Pradesh, India, D1843R00282
        • Research Site
    • Assam
      • Dibrugarh, Assam, India, D1843R00282
        • Research Site
      • Guwahati, Assam, India, D1843R00282
        • Research Site
      • Nagaon, Assam, India, D1843R00282
        • Research Site
      • Silchar, Assam, India, D1843R00282
        • Research Site
      • Tinsukia, Assam, India, D1843R00282
        • Research Site
    • Bihar
      • Bhagalpur, Bihar, India, D1843R00282
        • Research Site
      • Gaya, Bihar, India, D1843R00282
        • Research Site
      • Patna, Bihar, India, D1843R00282
        • Research Site
      • Samastipur, Bihar, India, D1843R00282
        • Research Site
      • Samstipur, Bihar, India, D1843R00282
        • Research Site
    • Chhattisgarh
      • Bhilai, Chhattisgarh, India, D1843R00282
        • Research Site
      • Durg, Chhattisgarh, India, D1843R00282
        • Research Site
      • Raipur, Chhattisgarh, India, D1843R00282
        • Research Site
      • Rohtak, Chhattisgarh, India, D1843R00282
        • Research Site
    • Delhi
      • New Delhi, Delhi, India, D1843R00282
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, India, D1843R00282
        • Research Site
      • Amreli, Gujarat, India, D1843R00282
        • Research Site
      • Anand, Gujarat, India, D1843R00282
        • Research Site
      • Bharuch, Gujarat, India, D1843R00282
        • Research Site
      • Bhavnagar, Gujarat, India, D1843R00282
        • Research Site
      • Bhuj, Gujarat, India, D1843R00282
        • Research Site
      • Borsad, Gujarat, India, D1843R00282
        • Research Site
      • Botad, Gujarat, India, D1843R00282
        • Research Site
      • Chaibasa, Gujarat, India, D1843R00282
        • Research Site
      • Dahod, Gujarat, India, D1843R00282
        • Research Site
      • Himatnagar, Gujarat, India, D1843R00282
        • Research Site
      • Jamnagar, Gujarat, India, D1843R00282
        • Research Site
      • Junagadh, Gujarat, India, D1843R00282
        • Research Site
      • Kutch, Gujarat, India, D1843R00282
        • Research Site
      • Morbi, Gujarat, India, D1843R00282
        • Research Site
      • Nadiad, Gujarat, India, D1843R00282
        • Research Site
      • Navsari, Gujarat, India, D1843R00282
        • Research Site
      • Patan, Gujarat, India, D1843R00282
        • Research Site
      • Porbandar, Gujarat, India, D1843R00282
        • Research Site
      • Rajkot, Gujarat, India, D1843R00282
        • Research Site
      • Surat, Gujarat, India, D1843R00282
        • Research Site
      • Unnao, Gujarat, India, D1843R00282
        • Research Site
      • Vadodara, Gujarat, India, D1843R00282
        • Research Site
      • Valsad, Gujarat, India, D1843R00282
        • Research Site
      • Vapi, Gujarat, India, D1843R00282
        • Research Site
    • Haryana
      • Bangalore, Haryana, India, D1843R00282
        • Research Site
      • Faridabad, Haryana, India, D1843R00282
        • Research Site
      • Gurugram, Haryana, India, D1843R00282
        • Research Site
      • Hisar, Haryana, India, D1843R00282
        • Research Site
      • Panchkula, Haryana, India, D1843R00282
        • Research Site
      • Panipat, Haryana, India, D1843R00282
        • Research Site
      • Rohtak, Haryana, India, D1843R00282
        • Research Site
      • Sonipat, Haryana, India, D1843R00282
        • Research Site
      • Yamunanagar, Haryana, India, D1843R00282
        • Research Site
    • Himachal Pradesh
      • Mandi, Himachal Pradesh, India, D1843R00282
        • Research Site
    • Jammu And Kashmir
      • Srinagar, Jammu And Kashmir, India, D1843R00282
        • Research Site
    • Jharkhand
      • Jamshedpur, Jharkhand, India, D1843R00282
        • Research Site
      • Ranchi, Jharkhand, India, D1843R00282
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India, D1843R00282
        • Research Site
      • Belgaum, Karnataka, India, D1843R00282
        • Research Site
      • Gulbarga, Karnataka, India, D1843R00282
        • Research Site
    • Kerala
      • Angamaly, Kerala, India, D1843R00282
        • Research Site
      • Chengannur, Kerala, India, D1843R00282
        • Research Site
      • Edappally, Kerala, India, D1843R00282
        • Research Site
      • Ernakulam, Kerala, India, D1843R00282
        • Research Site
      • Idukki, Kerala, India, D1843R00282
        • Research Site
      • Kochi, Kerala, India, D1843R00282
        • Research Site
      • Kollam, Kerala, India, D1843R00282
        • Research Site
      • Kottayam, Kerala, India, D1843R00282
        • Research Site
      • Malappuram, Kerala, India, D1843R00282
        • Research Site
      • Nedumangad, Kerala, India, D1843R00282
        • Research Site
      • Palakkad, Kerala, India, D1843R00282
        • Research Site
      • Pezhakkappilly, Kerala, India, D1843R00282
        • Research Site
      • Thalassery, Kerala, India, D1843R00282
        • Research Site
      • Thiruvananthapuram, Kerala, India, D1843R00282
        • Research Site
      • Thrissur, Kerala, India, D1843R00282
        • Research Site
      • Trivandrum, Kerala, India, D1843R00282
        • Research Site
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India, D1843R00282
        • Research Site
      • Guna, Madhya Pradesh, India, D1843R00282
        • Research Site
      • Gwalior, Madhya Pradesh, India, D1843R00282
        • Research Site
      • Indore, Madhya Pradesh, India, D1843R00282
        • Research Site
      • Jabalpur, Madhya Pradesh, India, D1843R00282
        • Research Site
      • Mandsaur, Madhya Pradesh, India, D1843R00282
        • Research Site
      • Ujjain, Madhya Pradesh, India, D1843R00282
        • Research Site
    • Maharastra
      • Ahmednagar, Maharastra, India, D1843R00282
        • Research Site
      • Aurangabad, Maharastra, India, D1843R00282
        • Research Site
      • Bhiwandi, Maharastra, India, D1843R00282
        • Research Site
      • Kalyan, Maharastra, India, D1843R00282
        • Research Site
      • Kolhapur, Maharastra, India, D1843R00282
        • Research Site
      • Mumbai, Maharastra, India, D1843R00282
        • Research Site
      • Nagpur, Maharastra, India, D1843R00282
        • Research Site
      • Nasik, Maharastra, India, D1843R00282
        • Research Site
      • Navi Mumbai, Maharastra, India, D1843R00282
        • Research Site
      • Palanpur, Maharastra, India, D1843R00282
        • Research Site
      • Palghar, Maharastra, India, D1843R00282
        • Research Site
      • Pune, Maharastra, India, D1843R00282
        • Research Site
      • Raigad, Maharastra, India, D1843R00282
        • Research Site
      • Rajkot, Maharastra, India, D1843R00282
        • Research Site
      • Sangli, Maharastra, India, D1843R00282
        • Research Site
      • Satara, Maharastra, India, D1843R00282
        • Research Site
      • Sindhudurg, Maharastra, India, D1843R00282
        • Research Site
      • Solapur, Maharastra, India, D1843R00282
        • Research Site
      • Thane, Maharastra, India, D1843R00282
        • Research Site
      • Vasai, Maharastra, India, D1843R00282
        • Research Site
    • Manipur
      • Imphal, Manipur, India, D1843R00282
        • Research Site
    • Meghalaya
      • Shillong, Meghalaya, India, D1843R00282
        • Research Site
    • Odisha
      • Berhampur, Odisha, India, D1843R00282
        • Research Site
      • Bhubaneswar, Odisha, India, D1843R00282
        • Research Site
      • Bhubneshwar, Odisha, India, D1843R00282
        • Research Site
      • Bhuvaneshwar, Odisha, India, D1843R00282
        • Research Site
      • Cuttack, Odisha, India, D1843R00282
        • Research Site
      • Cuttuck, Odisha, India, D1843R00282
        • Research Site
      • Paradip, Odisha, India, D1843R00282
        • Research Site
      • Puri, Odisha, India, D1843R00282
        • Research Site
      • Rourkela, Odisha, India, D1843R00282
        • Research Site
      • Sambalpur, Odisha, India, D1843R00282
        • Research Site
    • Panjab
      • Amritsar, Panjab, India, D1843R00282
        • Research Site
      • Jalandhar, Panjab, India, D1843R00282
        • Research Site
      • Khanna, Panjab, India, D1843R00282
        • Research Site
      • Kharar, Panjab, India, D1843R00282
        • Research Site
      • Ludhiana, Panjab, India, D1843R00282
        • Research Site
      • Moga, Panjab, India, D1843R00282
        • Research Site
      • Patiala, Panjab, India, D1843R00282
        • Research Site
    • Rajasthan
      • Ajmer, Rajasthan, India, D1843R00282
        • Research Site
      • Ambala, Rajasthan, India, D1843R00282
        • Research Site
      • Bikaner, Rajasthan, India, D1843R00282
        • Research Site
      • Hanumangarh, Rajasthan, India, D1843R00282
        • Research Site
      • Jaipur, Rajasthan, India, D1843R00282
        • Research Site
      • Jamshedpur, Rajasthan, India, D1843R00282
        • Research Site
      • Jodhpur, Rajasthan, India, D1843R00282
        • Research Site
      • Kota, Rajasthan, India, D1843R00282
        • Research Site
      • Udaipur, Rajasthan, India, D1843R00282
        • Research Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, D1843R00282
        • Research Site
      • Coimbatore, Tamil Nadu, India, D1843R00282
        • Research Site
      • Erode, Tamil Nadu, India, D1843R00282
        • Research Site
      • Hosur, Tamil Nadu, India, D1843R00282
        • Research Site
      • Kanchipuram, Tamil Nadu, India, D1843R00282
        • Research Site
      • Kochi, Tamil Nadu, India, D1843R00282
        • Research Site
      • Kumbakonam, Tamil Nadu, India, D1843R00282
        • Research Site
      • Madurai, Tamil Nadu, India, D1843R00282
        • Research Site
      • Nagerkoil, Tamil Nadu, India, D1843R00282
        • Research Site
      • Pattukottai, Tamil Nadu, India, D1843R00282
        • Research Site
      • Pondicherry, Tamil Nadu, India, D1843R00282
        • Research Site
      • Ranipet, Tamil Nadu, India, D1843R00282
        • Research Site
      • Salem, Tamil Nadu, India, D1843R00282
        • Research Site
      • Thanjavur, Tamil Nadu, India, D1843R00282
        • Research Site
      • Thiruvannamalai, Tamil Nadu, India, D1843R00282
        • Research Site
      • Thiruvarur, Tamil Nadu, India, D1843R00282
        • Research Site
      • Trichy, Tamil Nadu, India, D1843R00282
        • Research Site
      • Vellore, Tamil Nadu, India, D1843R00282
        • Research Site
    • Telangana
      • Hyderabad, Telangana, India, D1843R00282
        • Research Site
      • Karimnagar, Telangana, India, D1843R00282
        • Research Site
      • Secunderabad, Telangana, India, D1843R00282
        • Research Site
    • Uttar Pradesh
      • Agra, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Aligarh, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Allahabad, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Bareilly, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Bareli, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Bulandshahr, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Etawah, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Faizabad, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Firozabad, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Ghaziabad, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Gorakhpur, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Hathras, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Jhansi, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Kanpur, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Karnal, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Lucknow, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Meerut, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Moradabad, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Noida, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Piliphit, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Rampur, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Varanasi, Uttar Pradesh, India, D1843R00282
        • Research Site
    • Uttarakhand
      • Dehradun, Uttarakhand, India, D1843R00282
        • Research Site
      • Haldwani, Uttarakhand, India, D1843R00282
        • Research Site
    • West Bengal
      • Baguihati, West Bengal, India, D1843R00282
        • Research Site
      • Basirhat, West Bengal, India, D1843R00282
        • Research Site
      • Bolapur, West Bengal, India, D1843R00282
        • Research Site
      • Burdwan, West Bengal, India, D1843R00282
        • Research Site
      • Durgapur, West Bengal, India, D1843R00282
        • Research Site
      • Guwahati, West Bengal, India, D1843R00282
        • Research Site
      • Habra, West Bengal, India, D1843R00282
        • Research Site
      • Hooghly, West Bengal, India, D1843R00282
        • Research Site
      • Howrah, West Bengal, India, D1843R00282
        • Research Site
      • Hubli, West Bengal, India, D1843R00282
        • Research Site
      • Jalpaiguri, West Bengal, India, D1843R00282
        • Research Site
      • Kharagpur, West Bengal, India, D1843R00282
        • Research Site
      • Kolkata, West Bengal, India, D1843R00282
        • Research Site
      • Malda, West Bengal, India, D1843R00282
        • Research Site
      • Nadia, West Bengal, India, D1843R00282
        • Research Site
      • Siliguri, West Bengal, India, D1843R00282
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 99 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Diabetes Mellitus patients

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
1
Diabetes Mellitus

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To evaluate total body fat content across various BMI categories in the study population
Periodo de tiempo: 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.
1 day

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To analyse different characteristics of Diabetes Mellitus patient in study population
Periodo de tiempo: 1 day
patient characteristics like age, gender
1 day
To correlate HbA1C level with various BMI categories
Periodo de tiempo: 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
1 day

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de diciembre de 2017

Finalización primaria (Actual)

14 de junio de 2019

Finalización del estudio (Actual)

14 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

20 de noviembre de 2017

Primero enviado que cumplió con los criterios de control de calidad

30 de noviembre de 2017

Publicado por primera vez (Actual)

6 de diciembre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de junio de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

12 de junio de 2020

Última verificación

1 de junio de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D1843R00282

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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