NCT03363594

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

197 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

December 11, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

1.5 years

First QC Date

November 20, 2017

Last Update Submit

June 12, 2020

Conditions

Keywords

Diabetes, T2D

Outcome Measures

Primary Outcomes (1)

  • To evaluate total body fat content across various BMI categories in the study population

    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

Secondary Outcomes (2)

  • To analyse different characteristics of Diabetes Mellitus patient in study population

    1 day

  • To correlate HbA1C level with various BMI categories

    1 day

Study Arms (1)

1

Diabetes Mellitus

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetes Mellitus patients

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (197)

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Guntur, Andhra Pradesh, D1843R00282, India

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Kākināda, Andhra Pradesh, D1843R00282, India

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Madanapalle, Andhra Pradesh, D1843R00282, India

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Nellore, Andhra Pradesh, D1843R00282, India

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Rajahmundry, Andhra Pradesh, D1843R00282, India

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Vijaywada, Andhra Pradesh, D1843R00282, India

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Visakhapatnam, Andhra Pradesh, D1843R00282, India

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Dibrugarh, Assam, D1843R00282, India

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Guwahati, Assam, D1843R00282, India

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Nagaon, Assam, D1843R00282, India

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Silchar, Assam, D1843R00282, India

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Tinsukia, Assam, D1843R00282, India

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Bhagalpur, Bihar, D1843R00282, India

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Gaya, Bihar, D1843R00282, India

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Patna, Bihar, D1843R00282, India

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Samāstipur, Bihar, D1843R00282, India

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Samstipur, Bihar, D1843R00282, India

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Bhilai, Chhattisgarh, D1843R00282, India

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Durg, Chhattisgarh, D1843R00282, India

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Raipur, Chhattisgarh, D1843R00282, India

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Rohtak, Chhattisgarh, D1843R00282, India

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Ahmedabad, Gujarat, D1843R00282, India

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Amreli, Gujarat, D1843R00282, India

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Anand, Gujarat, D1843R00282, India

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Bharūch, Gujarat, D1843R00282, India

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Bhavnagar, Gujarat, D1843R00282, India

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Bhuj, Gujarat, D1843R00282, India

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Borsad, Gujarat, D1843R00282, India

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Botad, Gujarat, D1843R00282, India

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Chaibasa, Gujarat, D1843R00282, India

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Dohad, Gujarat, D1843R00282, India

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Himatnagar, Gujarat, D1843R00282, India

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Jamnagar, Gujarat, D1843R00282, India

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Jūnāgadh, Gujarat, D1843R00282, India

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Kutch, Gujarat, D1843R00282, India

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Morvi, Gujarat, D1843R00282, India

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Nadiād, Gujarat, D1843R00282, India

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Navsari, Gujarat, D1843R00282, India

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Pātan, Gujarat, D1843R00282, India

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Porbandar, Gujarat, D1843R00282, India

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Rajkot, Gujarat, D1843R00282, India

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Surat, Gujarat, D1843R00282, India

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Unnao, Gujarat, D1843R00282, India

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Vadodara, Gujarat, D1843R00282, India

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Valsād, Gujarat, D1843R00282, India

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Vapi, Gujarat, D1843R00282, India

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Bangalore, Haryana, D1843R00282, India

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Faridabad, Haryana, D1843R00282, India

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Gurugram, Haryana, D1843R00282, India

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Hisar, Haryana, D1843R00282, India

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Panchkula, Haryana, D1843R00282, India

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Panipat, Haryana, D1843R00282, India

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Rohtak, Haryana, D1843R00282, India

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Sonīpat, Haryana, D1843R00282, India

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Yamuna Nagar, Haryana, D1843R00282, India

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Mandi, Himachal Pradesh, D1843R00282, India

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Srinagar, Jammu and Kashmir, D1843R00282, India

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Jamshedpur, Jharkhand, D1843R00282, India

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Ranchi, Jharkhand, D1843R00282, India

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Bangalore, Karnataka, D1843R00282, India

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Belagavi, Karnataka, D1843R00282, India

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Kalaburagi, Karnataka, D1843R00282, India

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Angamaly, Kerala, D1843R00282, India

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Chengannūr, Kerala, D1843R00282, India

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Edappally, Kerala, D1843R00282, India

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Ernākulam, Kerala, D1843R00282, India

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Idukki, Kerala, D1843R00282, India

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Kochi, Kerala, D1843R00282, India

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Kollam, Kerala, D1843R00282, India

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Kottayam, Kerala, D1843R00282, India

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Malappuram, Kerala, D1843R00282, India

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Nedumangād, Kerala, D1843R00282, India

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Palakkad, Kerala, D1843R00282, India

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Pezhakkappilly, Kerala, D1843R00282, India

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Thalassery, Kerala, D1843R00282, India

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Thiruvananthapuram, Kerala, D1843R00282, India

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Thrissur, Kerala, D1843R00282, India

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Trivandrum, Kerala, D1843R00282, India

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Bhopal, Madhya Pradesh, D1843R00282, India

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Guna, Madhya Pradesh, D1843R00282, India

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Gwalior, Madhya Pradesh, D1843R00282, India

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Indore, Madhya Pradesh, D1843R00282, India

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Jabalpur, Madhya Pradesh, D1843R00282, India

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Mandsaur, Madhya Pradesh, D1843R00282, India

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Ujjain, Madhya Pradesh, D1843R00282, India

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Ahilyanagar, Maharashtra, D1843R00282, India

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Aurangabad, Maharashtra, D1843R00282, India

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Bhiwandi, Maharashtra, D1843R00282, India

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Kalyān, Maharashtra, D1843R00282, India

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Kolhāpur, Maharashtra, D1843R00282, India

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Mumbai, Maharashtra, D1843R00282, India

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Nagpur, Maharashtra, D1843R00282, India

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Nashik, Maharashtra, D1843R00282, India

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Navi Mumbai, Maharashtra, D1843R00282, India

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Palanpur, Maharashtra, D1843R00282, India

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Pālghar, Maharashtra, D1843R00282, India

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Pune, Maharashtra, D1843R00282, India

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Raigad, Maharashtra, D1843R00282, India

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Rajkot, Maharashtra, D1843R00282, India

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Sangli, Maharashtra, D1843R00282, India

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Satara, Maharashtra, D1843R00282, India

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Sindhudurg, Maharashtra, D1843R00282, India

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Solapur, Maharashtra, D1843R00282, India

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Thane, Maharashtra, D1843R00282, India

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Vasai, Maharashtra, D1843R00282, India

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Imphal, Manipur, D1843R00282, India

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Shillong, Meghālaya, D1843R00282, India

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New Delhi, National Capital Territory of Delhi, D1843R00282, India

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Berhampur, Odisha, D1843R00282, India

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Bhubaneswar, Odisha, D1843R00282, India

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Bhubneshwar, Odisha, D1843R00282, India

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Bhuvaneshwar, Odisha, D1843R00282, India

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Cuttack, Odisha, D1843R00282, India

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Cuttuck, Odisha, D1843R00282, India

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Paradip, Odisha, D1843R00282, India

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Puri, Odisha, D1843R00282, India

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Rourkela, Odisha, D1843R00282, India

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Sambalpur, Odisha, D1843R00282, India

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Amritsar, Punjab, D1843R00282, India

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Jalandhar, Punjab, D1843R00282, India

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Khanna, Punjab, D1843R00282, India

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Kharar, Punjab, D1843R00282, India

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Ludhiana, Punjab, D1843R00282, India

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Moga, Punjab, D1843R00282, India

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Patiāla, Punjab, D1843R00282, India

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Ajmer, Rajasthan, D1843R00282, India

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Ambala, Rajasthan, D1843R00282, India

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Bikaner, Rajasthan, D1843R00282, India

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Hanumāngarh, Rajasthan, D1843R00282, India

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Jaipur, Rajasthan, D1843R00282, India

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Jamshedpur, Rajasthan, D1843R00282, India

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Jodhpur, Rajasthan, D1843R00282, India

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Kota, Rajasthan, D1843R00282, India

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Udaipur, Rajasthan, D1843R00282, India

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Chennai, Tamil Nadu, D1843R00282, India

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Coimbatore, Tamil Nadu, D1843R00282, India

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Erode, Tamil Nadu, D1843R00282, India

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Hosūr, Tamil Nadu, D1843R00282, India

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Kanchipuram, Tamil Nadu, D1843R00282, India

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Kochi, Tamil Nadu, D1843R00282, India

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Kumbakonam, Tamil Nadu, D1843R00282, India

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Madurai, Tamil Nadu, D1843R00282, India

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Nagerkoil, Tamil Nadu, D1843R00282, India

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Pattukkottai, Tamil Nadu, D1843R00282, India

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Pondicherry, Tamil Nadu, D1843R00282, India

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Ranipet, Tamil Nadu, D1843R00282, India

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Salem, Tamil Nadu, D1843R00282, India

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Thanjavur, Tamil Nadu, D1843R00282, India

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Thiruvannamalai, Tamil Nadu, D1843R00282, India

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Thiruvarur, Tamil Nadu, D1843R00282, India

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Trichy, Tamil Nadu, D1843R00282, India

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Vellore, Tamil Nadu, D1843R00282, India

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Hyderabad, Telangana, D1843R00282, India

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Karīmnagar, Telangana, D1843R00282, India

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Secunderabad, Telangana, D1843R00282, India

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Agra, Uttar Pradesh, D1843R00282, India

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Aligarh, Uttar Pradesh, D1843R00282, India

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Allahābād, Uttar Pradesh, D1843R00282, India

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Bareilly, Uttar Pradesh, D1843R00282, India

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Bareli, Uttar Pradesh, D1843R00282, India

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Bulandshahr, Uttar Pradesh, D1843R00282, India

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Etāwah, Uttar Pradesh, D1843R00282, India

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Faizabad, Uttar Pradesh, D1843R00282, India

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Firozabad, Uttar Pradesh, D1843R00282, India

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Ghaziabad, Uttar Pradesh, D1843R00282, India

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Gorakhpur, Uttar Pradesh, D1843R00282, India

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Hāthras, Uttar Pradesh, D1843R00282, India

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Jhānsi, Uttar Pradesh, D1843R00282, India

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Kanpur, Uttar Pradesh, D1843R00282, India

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Karnal, Uttar Pradesh, D1843R00282, India

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Lucknow, Uttar Pradesh, D1843R00282, India

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Meerut, Uttar Pradesh, D1843R00282, India

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Morādābād, Uttar Pradesh, D1843R00282, India

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Noida, Uttar Pradesh, D1843R00282, India

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Piliphit, Uttar Pradesh, D1843R00282, India

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Rāmpur, Uttar Pradesh, D1843R00282, India

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Varanasi, Uttar Pradesh, D1843R00282, India

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Dehradun, Uttarakhand, D1843R00282, India

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Haldwani, Uttarakhand, D1843R00282, India

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Baguihati, West Bengal, D1843R00282, India

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Basīrhat, West Bengal, D1843R00282, India

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Bolapur, West Bengal, D1843R00282, India

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Burdwan, West Bengal, D1843R00282, India

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Durgapur, West Bengal, D1843R00282, India

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Guwahati, West Bengal, D1843R00282, India

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Hābra, West Bengal, D1843R00282, India

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Howrah, West Bengal, D1843R00282, India

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Hubli, West Bengal, D1843R00282, India

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Hugli, West Bengal, D1843R00282, India

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Jalpāiguri, West Bengal, D1843R00282, India

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Kharagpur, West Bengal, D1843R00282, India

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Kolkata, West Bengal, D1843R00282, India

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Malda, West Bengal, D1843R00282, India

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Nabadwip, West Bengal, D1843R00282, India

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Siliguri, West Bengal, D1843R00282, India

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Chandigarh, D1843R00282, India

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Goa, D1843R00282, India

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Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 6, 2017

Study Start

December 11, 2017

Primary Completion

June 14, 2019

Study Completion

June 14, 2019

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations