Indian Phenotype Registry (IP Registry)
12. června 2020 aktualizováno: 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).
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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
Typ studie
Pozorovací
Zápis (Aktuální)
40000
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Chandigarh, Indie, D1843R00282
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Goa, Indie, D1843R00282
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Andhra Pradesh
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Guntur, Andhra Pradesh, Indie, D1843R00282
- Research Site
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Kakinada, Andhra Pradesh, Indie, D1843R00282
- Research Site
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Madanapalle, Andhra Pradesh, Indie, D1843R00282
- Research Site
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Nellore, Andhra Pradesh, Indie, D1843R00282
- Research Site
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Rajahmundry, Andhra Pradesh, Indie, D1843R00282
- Research Site
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Vijaywada, Andhra Pradesh, Indie, D1843R00282
- Research Site
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Visakhapatnam, Andhra Pradesh, Indie, D1843R00282
- Research Site
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Assam
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Dibrugarh, Assam, Indie, D1843R00282
- Research Site
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Guwahati, Assam, Indie, D1843R00282
- Research Site
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Nagaon, Assam, Indie, D1843R00282
- Research Site
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Silchar, Assam, Indie, D1843R00282
- Research Site
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Tinsukia, Assam, Indie, D1843R00282
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Bihar
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Bhagalpur, Bihar, Indie, D1843R00282
- Research Site
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Gaya, Bihar, Indie, D1843R00282
- Research Site
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Patna, Bihar, Indie, D1843R00282
- Research Site
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Samastipur, Bihar, Indie, D1843R00282
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Samstipur, Bihar, Indie, D1843R00282
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Chhattisgarh
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Bhilai, Chhattisgarh, Indie, D1843R00282
- Research Site
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Durg, Chhattisgarh, Indie, D1843R00282
- Research Site
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Raipur, Chhattisgarh, Indie, D1843R00282
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Rohtak, Chhattisgarh, Indie, D1843R00282
- Research Site
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Delhi
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New Delhi, Delhi, Indie, D1843R00282
- Research Site
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Gujarat
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Ahmedabad, Gujarat, Indie, D1843R00282
- Research Site
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Amreli, Gujarat, Indie, D1843R00282
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Anand, Gujarat, Indie, D1843R00282
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Bharuch, Gujarat, Indie, D1843R00282
- Research Site
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Bhavnagar, Gujarat, Indie, D1843R00282
- Research Site
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Bhuj, Gujarat, Indie, D1843R00282
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Borsad, Gujarat, Indie, D1843R00282
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Botad, Gujarat, Indie, D1843R00282
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Chaibasa, Gujarat, Indie, D1843R00282
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Dahod, Gujarat, Indie, D1843R00282
- Research Site
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Himatnagar, Gujarat, Indie, D1843R00282
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Jamnagar, Gujarat, Indie, D1843R00282
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Junagadh, Gujarat, Indie, D1843R00282
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Kutch, Gujarat, Indie, D1843R00282
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Morbi, Gujarat, Indie, D1843R00282
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Nadiad, Gujarat, Indie, D1843R00282
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Navsari, Gujarat, Indie, D1843R00282
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Patan, Gujarat, Indie, D1843R00282
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Porbandar, Gujarat, Indie, D1843R00282
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Rajkot, Gujarat, Indie, D1843R00282
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Surat, Gujarat, Indie, D1843R00282
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Unnao, Gujarat, Indie, D1843R00282
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Vadodara, Gujarat, Indie, D1843R00282
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Valsad, Gujarat, Indie, D1843R00282
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Vapi, Gujarat, Indie, D1843R00282
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Haryana
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Bangalore, Haryana, Indie, D1843R00282
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Faridabad, Haryana, Indie, D1843R00282
- Research Site
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Gurugram, Haryana, Indie, D1843R00282
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Hisar, Haryana, Indie, D1843R00282
- Research Site
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Panchkula, Haryana, Indie, D1843R00282
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Panipat, Haryana, Indie, D1843R00282
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Rohtak, Haryana, Indie, D1843R00282
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Sonipat, Haryana, Indie, D1843R00282
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Yamunanagar, Haryana, Indie, D1843R00282
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Himachal Pradesh
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Mandi, Himachal Pradesh, Indie, D1843R00282
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Jammu And Kashmir
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Srinagar, Jammu And Kashmir, Indie, D1843R00282
- Research Site
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Jharkhand
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Jamshedpur, Jharkhand, Indie, D1843R00282
- Research Site
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Ranchi, Jharkhand, Indie, D1843R00282
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Karnataka
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Bangalore, Karnataka, Indie, D1843R00282
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Belgaum, Karnataka, Indie, D1843R00282
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Gulbarga, Karnataka, Indie, D1843R00282
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Kerala
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Angamaly, Kerala, Indie, D1843R00282
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Chengannur, Kerala, Indie, D1843R00282
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Edappally, Kerala, Indie, D1843R00282
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Ernakulam, Kerala, Indie, D1843R00282
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Idukki, Kerala, Indie, D1843R00282
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Kochi, Kerala, Indie, D1843R00282
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Kollam, Kerala, Indie, D1843R00282
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Kottayam, Kerala, Indie, D1843R00282
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Malappuram, Kerala, Indie, D1843R00282
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Nedumangad, Kerala, Indie, D1843R00282
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Palakkad, Kerala, Indie, D1843R00282
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Pezhakkappilly, Kerala, Indie, D1843R00282
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Thalassery, Kerala, Indie, D1843R00282
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Thiruvananthapuram, Kerala, Indie, D1843R00282
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Thrissur, Kerala, Indie, D1843R00282
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Trivandrum, Kerala, Indie, D1843R00282
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Madhya Pradesh
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Bhopal, Madhya Pradesh, Indie, D1843R00282
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Guna, Madhya Pradesh, Indie, D1843R00282
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Gwalior, Madhya Pradesh, Indie, D1843R00282
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Indore, Madhya Pradesh, Indie, D1843R00282
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Jabalpur, Madhya Pradesh, Indie, D1843R00282
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Mandsaur, Madhya Pradesh, Indie, D1843R00282
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Ujjain, Madhya Pradesh, Indie, D1843R00282
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Maharastra
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Ahmednagar, Maharastra, Indie, D1843R00282
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Aurangabad, Maharastra, Indie, D1843R00282
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Bhiwandi, Maharastra, Indie, D1843R00282
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Kalyan, Maharastra, Indie, D1843R00282
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Kolhapur, Maharastra, Indie, D1843R00282
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Mumbai, Maharastra, Indie, D1843R00282
- Research Site
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Nagpur, Maharastra, Indie, D1843R00282
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Nasik, Maharastra, Indie, D1843R00282
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Navi Mumbai, Maharastra, Indie, D1843R00282
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Palanpur, Maharastra, Indie, D1843R00282
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Palghar, Maharastra, Indie, D1843R00282
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Pune, Maharastra, Indie, D1843R00282
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Raigad, Maharastra, Indie, D1843R00282
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Rajkot, Maharastra, Indie, D1843R00282
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Sangli, Maharastra, Indie, D1843R00282
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Satara, Maharastra, Indie, D1843R00282
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Sindhudurg, Maharastra, Indie, D1843R00282
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Solapur, Maharastra, Indie, D1843R00282
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Thane, Maharastra, Indie, D1843R00282
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Vasai, Maharastra, Indie, D1843R00282
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Manipur
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Imphal, Manipur, Indie, D1843R00282
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Meghalaya
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Shillong, Meghalaya, Indie, D1843R00282
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Odisha
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Berhampur, Odisha, Indie, D1843R00282
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Bhubaneswar, Odisha, Indie, D1843R00282
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Bhubneshwar, Odisha, Indie, D1843R00282
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Bhuvaneshwar, Odisha, Indie, D1843R00282
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Cuttack, Odisha, Indie, D1843R00282
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Cuttuck, Odisha, Indie, D1843R00282
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Paradip, Odisha, Indie, D1843R00282
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Puri, Odisha, Indie, D1843R00282
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Rourkela, Odisha, Indie, D1843R00282
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Sambalpur, Odisha, Indie, D1843R00282
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Panjab
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Amritsar, Panjab, Indie, D1843R00282
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Jalandhar, Panjab, Indie, D1843R00282
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Khanna, Panjab, Indie, D1843R00282
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Kharar, Panjab, Indie, D1843R00282
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Ludhiana, Panjab, Indie, D1843R00282
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Moga, Panjab, Indie, D1843R00282
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Patiala, Panjab, Indie, D1843R00282
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Rajasthan
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Ajmer, Rajasthan, Indie, D1843R00282
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Ambala, Rajasthan, Indie, D1843R00282
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Bikaner, Rajasthan, Indie, D1843R00282
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Hanumangarh, Rajasthan, Indie, D1843R00282
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Jaipur, Rajasthan, Indie, D1843R00282
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Jamshedpur, Rajasthan, Indie, D1843R00282
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Jodhpur, Rajasthan, Indie, D1843R00282
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Kota, Rajasthan, Indie, D1843R00282
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Udaipur, Rajasthan, Indie, D1843R00282
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Tamil Nadu
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Chennai, Tamil Nadu, Indie, D1843R00282
- Research Site
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Coimbatore, Tamil Nadu, Indie, D1843R00282
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Erode, Tamil Nadu, Indie, D1843R00282
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Hosur, Tamil Nadu, Indie, D1843R00282
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Kanchipuram, Tamil Nadu, Indie, D1843R00282
- Research Site
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Kochi, Tamil Nadu, Indie, D1843R00282
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Kumbakonam, Tamil Nadu, Indie, D1843R00282
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Madurai, Tamil Nadu, Indie, D1843R00282
- Research Site
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Nagerkoil, Tamil Nadu, Indie, D1843R00282
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Pattukottai, Tamil Nadu, Indie, D1843R00282
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Pondicherry, Tamil Nadu, Indie, D1843R00282
- Research Site
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Ranipet, Tamil Nadu, Indie, D1843R00282
- Research Site
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Salem, Tamil Nadu, Indie, D1843R00282
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Thanjavur, Tamil Nadu, Indie, D1843R00282
- Research Site
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Thiruvannamalai, Tamil Nadu, Indie, D1843R00282
- Research Site
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Thiruvarur, Tamil Nadu, Indie, D1843R00282
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Trichy, Tamil Nadu, Indie, D1843R00282
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Vellore, Tamil Nadu, Indie, D1843R00282
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Telangana
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Hyderabad, Telangana, Indie, D1843R00282
- Research Site
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Karimnagar, Telangana, Indie, D1843R00282
- Research Site
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Secunderabad, Telangana, Indie, D1843R00282
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Uttar Pradesh
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Agra, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Aligarh, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Allahabad, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Bareilly, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Bareli, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Bulandshahr, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Etawah, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Faizabad, Uttar Pradesh, Indie, D1843R00282
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Firozabad, Uttar Pradesh, Indie, D1843R00282
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Ghaziabad, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Gorakhpur, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Hathras, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Jhansi, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Kanpur, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Karnal, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Lucknow, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Meerut, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Moradabad, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Noida, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Piliphit, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Rampur, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Varanasi, Uttar Pradesh, Indie, D1843R00282
- Research Site
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Uttarakhand
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Dehradun, Uttarakhand, Indie, D1843R00282
- Research Site
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Haldwani, Uttarakhand, Indie, D1843R00282
- Research Site
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West Bengal
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Baguihati, West Bengal, Indie, D1843R00282
- Research Site
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Basirhat, West Bengal, Indie, D1843R00282
- Research Site
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Bolapur, West Bengal, Indie, D1843R00282
- Research Site
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Burdwan, West Bengal, Indie, D1843R00282
- Research Site
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Durgapur, West Bengal, Indie, D1843R00282
- Research Site
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Guwahati, West Bengal, Indie, D1843R00282
- Research Site
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Habra, West Bengal, Indie, D1843R00282
- Research Site
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Hooghly, West Bengal, Indie, D1843R00282
- Research Site
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Howrah, West Bengal, Indie, D1843R00282
- Research Site
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Hubli, West Bengal, Indie, D1843R00282
- Research Site
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Jalpaiguri, West Bengal, Indie, D1843R00282
- Research Site
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Kharagpur, West Bengal, Indie, D1843R00282
- Research Site
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Kolkata, West Bengal, Indie, D1843R00282
- Research Site
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Malda, West Bengal, Indie, D1843R00282
- Research Site
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Nadia, West Bengal, Indie, D1843R00282
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Siliguri, West Bengal, Indie, D1843R00282
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 99 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Diabetes Mellitus patients
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
1
Diabetes Mellitus
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
To evaluate total body fat content across various BMI categories in the study population
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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To analyse different characteristics of Diabetes Mellitus patient in study population
Časové okno: 1 day
|
patient characteristics like age, gender
|
1 day
|
|
To correlate HbA1C level with various BMI categories
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
11. prosince 2017
Primární dokončení (Aktuální)
14. června 2019
Dokončení studie (Aktuální)
14. června 2019
Termíny zápisu do studia
První předloženo
20. listopadu 2017
První předloženo, které splnilo kritéria kontroly kvality
30. listopadu 2017
První zveřejněno (Aktuální)
6. prosince 2017
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
16. června 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. června 2020
Naposledy ověřeno
1. června 2020
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- D1843R00282
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .