- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03363594
Indian Phenotype Registry (IP Registry)
A Non-interventional Nationwide Registry to Identify Indian Phenotype Characteristics in Diabetes Mellitus Patients in India.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Chandigarh, India, D1843R00282
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Goa, India, D1843R00282
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Andhra Pradesh
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Guntur, Andhra Pradesh, India, D1843R00282
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Kakinada, Andhra Pradesh, India, D1843R00282
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Madanapalle, Andhra Pradesh, India, D1843R00282
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Nellore, Andhra Pradesh, India, D1843R00282
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Rajahmundry, Andhra Pradesh, India, D1843R00282
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Vijaywada, Andhra Pradesh, India, D1843R00282
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Visakhapatnam, Andhra Pradesh, India, D1843R00282
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Assam
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Dibrugarh, Assam, India, D1843R00282
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Guwahati, Assam, India, D1843R00282
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Nagaon, Assam, India, D1843R00282
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Silchar, Assam, India, D1843R00282
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Tinsukia, Assam, India, D1843R00282
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Bihar
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Bhagalpur, Bihar, India, D1843R00282
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Gaya, Bihar, India, D1843R00282
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Patna, Bihar, India, D1843R00282
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Samastipur, Bihar, India, D1843R00282
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Samstipur, Bihar, India, D1843R00282
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Chhattisgarh
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Bhilai, Chhattisgarh, India, D1843R00282
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Durg, Chhattisgarh, India, D1843R00282
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Raipur, Chhattisgarh, India, D1843R00282
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Rohtak, Chhattisgarh, India, D1843R00282
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Delhi
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New Delhi, Delhi, India, D1843R00282
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Gujarat
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Ahmedabad, Gujarat, India, D1843R00282
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Amreli, Gujarat, India, D1843R00282
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Anand, Gujarat, India, D1843R00282
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Bharuch, Gujarat, India, D1843R00282
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Bhavnagar, Gujarat, India, D1843R00282
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Bhuj, Gujarat, India, D1843R00282
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Borsad, Gujarat, India, D1843R00282
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Botad, Gujarat, India, D1843R00282
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Chaibasa, Gujarat, India, D1843R00282
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Dahod, Gujarat, India, D1843R00282
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Himatnagar, Gujarat, India, D1843R00282
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Jamnagar, Gujarat, India, D1843R00282
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Junagadh, Gujarat, India, D1843R00282
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Kutch, Gujarat, India, D1843R00282
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Morbi, Gujarat, India, D1843R00282
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Nadiad, Gujarat, India, D1843R00282
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Navsari, Gujarat, India, D1843R00282
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Patan, Gujarat, India, D1843R00282
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Porbandar, Gujarat, India, D1843R00282
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Rajkot, Gujarat, India, D1843R00282
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Surat, Gujarat, India, D1843R00282
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Unnao, Gujarat, India, D1843R00282
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Vadodara, Gujarat, India, D1843R00282
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Valsad, Gujarat, India, D1843R00282
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Vapi, Gujarat, India, D1843R00282
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Haryana
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Bangalore, Haryana, India, D1843R00282
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Faridabad, Haryana, India, D1843R00282
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Gurugram, Haryana, India, D1843R00282
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Hisar, Haryana, India, D1843R00282
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Panchkula, Haryana, India, D1843R00282
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Panipat, Haryana, India, D1843R00282
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Rohtak, Haryana, India, D1843R00282
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Sonipat, Haryana, India, D1843R00282
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Yamunanagar, Haryana, India, D1843R00282
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Himachal Pradesh
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Mandi, Himachal Pradesh, India, D1843R00282
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Jammu And Kashmir
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Srinagar, Jammu And Kashmir, India, D1843R00282
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Jharkhand
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Jamshedpur, Jharkhand, India, D1843R00282
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Ranchi, Jharkhand, India, D1843R00282
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Karnataka
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Bangalore, Karnataka, India, D1843R00282
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Belgaum, Karnataka, India, D1843R00282
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Gulbarga, Karnataka, India, D1843R00282
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Kerala
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Angamaly, Kerala, India, D1843R00282
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Chengannur, Kerala, India, D1843R00282
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Edappally, Kerala, India, D1843R00282
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Ernakulam, Kerala, India, D1843R00282
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Idukki, Kerala, India, D1843R00282
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Kochi, Kerala, India, D1843R00282
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Kollam, Kerala, India, D1843R00282
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Kottayam, Kerala, India, D1843R00282
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Malappuram, Kerala, India, D1843R00282
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Nedumangad, Kerala, India, D1843R00282
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Palakkad, Kerala, India, D1843R00282
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Pezhakkappilly, Kerala, India, D1843R00282
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Thalassery, Kerala, India, D1843R00282
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Thiruvananthapuram, Kerala, India, D1843R00282
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Thrissur, Kerala, India, D1843R00282
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Trivandrum, Kerala, India, D1843R00282
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Madhya Pradesh
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Bhopal, Madhya Pradesh, India, D1843R00282
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Guna, Madhya Pradesh, India, D1843R00282
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Gwalior, Madhya Pradesh, India, D1843R00282
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Indore, Madhya Pradesh, India, D1843R00282
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Jabalpur, Madhya Pradesh, India, D1843R00282
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Mandsaur, Madhya Pradesh, India, D1843R00282
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Ujjain, Madhya Pradesh, India, D1843R00282
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Maharastra
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Ahmednagar, Maharastra, India, D1843R00282
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Aurangabad, Maharastra, India, D1843R00282
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Bhiwandi, Maharastra, India, D1843R00282
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Kalyan, Maharastra, India, D1843R00282
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Kolhapur, Maharastra, India, D1843R00282
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Mumbai, Maharastra, India, D1843R00282
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Nagpur, Maharastra, India, D1843R00282
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Nasik, Maharastra, India, D1843R00282
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Navi Mumbai, Maharastra, India, D1843R00282
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Palanpur, Maharastra, India, D1843R00282
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Palghar, Maharastra, India, D1843R00282
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Pune, Maharastra, India, D1843R00282
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Raigad, Maharastra, India, D1843R00282
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Rajkot, Maharastra, India, D1843R00282
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Sangli, Maharastra, India, D1843R00282
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Satara, Maharastra, India, D1843R00282
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Sindhudurg, Maharastra, India, D1843R00282
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Solapur, Maharastra, India, D1843R00282
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Thane, Maharastra, India, D1843R00282
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Vasai, Maharastra, India, D1843R00282
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Manipur
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Imphal, Manipur, India, D1843R00282
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Meghalaya
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Shillong, Meghalaya, India, D1843R00282
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Odisha
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Berhampur, Odisha, India, D1843R00282
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Bhubaneswar, Odisha, India, D1843R00282
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Bhubneshwar, Odisha, India, D1843R00282
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Bhuvaneshwar, Odisha, India, D1843R00282
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Cuttack, Odisha, India, D1843R00282
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Cuttuck, Odisha, India, D1843R00282
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Paradip, Odisha, India, D1843R00282
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Puri, Odisha, India, D1843R00282
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Rourkela, Odisha, India, D1843R00282
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Sambalpur, Odisha, India, D1843R00282
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Panjab
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Amritsar, Panjab, India, D1843R00282
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Jalandhar, Panjab, India, D1843R00282
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Khanna, Panjab, India, D1843R00282
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Kharar, Panjab, India, D1843R00282
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Ludhiana, Panjab, India, D1843R00282
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Moga, Panjab, India, D1843R00282
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Patiala, Panjab, India, D1843R00282
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Rajasthan
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Ajmer, Rajasthan, India, D1843R00282
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Ambala, Rajasthan, India, D1843R00282
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Bikaner, Rajasthan, India, D1843R00282
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Hanumangarh, Rajasthan, India, D1843R00282
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Jaipur, Rajasthan, India, D1843R00282
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Jamshedpur, Rajasthan, India, D1843R00282
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Jodhpur, Rajasthan, India, D1843R00282
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Kota, Rajasthan, India, D1843R00282
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Udaipur, Rajasthan, India, D1843R00282
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Tamil Nadu
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Chennai, Tamil Nadu, India, D1843R00282
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Coimbatore, Tamil Nadu, India, D1843R00282
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Erode, Tamil Nadu, India, D1843R00282
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Hosur, Tamil Nadu, India, D1843R00282
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Kanchipuram, Tamil Nadu, India, D1843R00282
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Kochi, Tamil Nadu, India, D1843R00282
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Kumbakonam, Tamil Nadu, India, D1843R00282
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Madurai, Tamil Nadu, India, D1843R00282
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Nagerkoil, Tamil Nadu, India, D1843R00282
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Pattukottai, Tamil Nadu, India, D1843R00282
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Pondicherry, Tamil Nadu, India, D1843R00282
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Ranipet, Tamil Nadu, India, D1843R00282
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Salem, Tamil Nadu, India, D1843R00282
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Thanjavur, Tamil Nadu, India, D1843R00282
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Thiruvannamalai, Tamil Nadu, India, D1843R00282
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Thiruvarur, Tamil Nadu, India, D1843R00282
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Trichy, Tamil Nadu, India, D1843R00282
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Vellore, Tamil Nadu, India, D1843R00282
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Telangana
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Hyderabad, Telangana, India, D1843R00282
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Karimnagar, Telangana, India, D1843R00282
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Secunderabad, Telangana, India, D1843R00282
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Uttar Pradesh
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Agra, Uttar Pradesh, India, D1843R00282
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Aligarh, Uttar Pradesh, India, D1843R00282
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Allahabad, Uttar Pradesh, India, D1843R00282
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Bareilly, Uttar Pradesh, India, D1843R00282
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Bareli, Uttar Pradesh, India, D1843R00282
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Bulandshahr, Uttar Pradesh, India, D1843R00282
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Etawah, Uttar Pradesh, India, D1843R00282
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Faizabad, Uttar Pradesh, India, D1843R00282
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Firozabad, Uttar Pradesh, India, D1843R00282
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Ghaziabad, Uttar Pradesh, India, D1843R00282
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Gorakhpur, Uttar Pradesh, India, D1843R00282
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Hathras, Uttar Pradesh, India, D1843R00282
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Jhansi, Uttar Pradesh, India, D1843R00282
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Kanpur, Uttar Pradesh, India, D1843R00282
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Karnal, Uttar Pradesh, India, D1843R00282
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Lucknow, Uttar Pradesh, India, D1843R00282
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Meerut, Uttar Pradesh, India, D1843R00282
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Moradabad, Uttar Pradesh, India, D1843R00282
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Noida, Uttar Pradesh, India, D1843R00282
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Piliphit, Uttar Pradesh, India, D1843R00282
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Rampur, Uttar Pradesh, India, D1843R00282
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Varanasi, Uttar Pradesh, India, D1843R00282
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Uttarakhand
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Dehradun, Uttarakhand, India, D1843R00282
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Haldwani, Uttarakhand, India, D1843R00282
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West Bengal
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Baguihati, West Bengal, India, D1843R00282
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Basirhat, West Bengal, India, D1843R00282
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Bolapur, West Bengal, India, D1843R00282
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Burdwan, West Bengal, India, D1843R00282
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Durgapur, West Bengal, India, D1843R00282
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Guwahati, West Bengal, India, D1843R00282
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Habra, West Bengal, India, D1843R00282
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Hooghly, West Bengal, India, D1843R00282
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Howrah, West Bengal, India, D1843R00282
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Hubli, West Bengal, India, D1843R00282
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Jalpaiguri, West Bengal, India, D1843R00282
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Kharagpur, West Bengal, India, D1843R00282
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Kolkata, West Bengal, India, D1843R00282
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Malda, West Bengal, India, D1843R00282
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Nadia, West Bengal, India, D1843R00282
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Siliguri, West Bengal, India, D1843R00282
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Diabetes Mellitus
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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To evaluate total body fat content across various BMI categories in the study population
Time Frame: 1 day
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To analyse different characteristics of Diabetes Mellitus patient in study population
Time Frame: 1 day
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patient characteristics like age, gender
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1 day
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To correlate HbA1C level with various BMI categories
Time Frame: 1 day
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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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1 day
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1843R00282
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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