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Indian Phenotype Registry (IP Registry)

12 czerwca 2020 zaktualizowane przez: 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).

Przegląd badań

Status

Zakończony

Warunki

Cukrzyca

Szczegółowy opis

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

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

40000

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 99 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Diabetes Mellitus patients

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
1 Diabetes Mellitus

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
To evaluate total body fat content across various BMI categories in the study population Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
To analyse different characteristics of Diabetes Mellitus patient in study population Ramy czasowe: 1 day	patient characteristics like age, gender	1 day
To correlate HbA1C level with various BMI categories Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AstraZeneca

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

redacted CSR synopsis

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

11 grudnia 2017

Zakończenie podstawowe (Rzeczywisty)

14 czerwca 2019

Ukończenie studiów (Rzeczywisty)

14 czerwca 2019

Daty rejestracji na studia

Pierwszy przesłany

20 listopada 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 listopada 2017

Pierwszy wysłany (Rzeczywisty)

6 grudnia 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 czerwca 2020

Ostatnia weryfikacja

1 czerwca 2020

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Diabetes, T2D

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

D1843R00282

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .