NCT02208921

Brief Summary

This non-interventional, multi-centric, cross-sectional study is aimed to determine the prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000 patients will be enrolled from 30 investigative sites all over the country. Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

18 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

August 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

August 4, 2014

Last Update Submit

March 24, 2016

Conditions

Diabetes

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • The proportion of T2DM patients with Chronic Kidney Disease (CKD)

    The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. GFR below 90 ml/min/1.73 m2 is defined as CKD. we will also classify CKD into various groups as per the KDIGO 2013.

    1 day

Secondary Outcomes (3)

  • Frequency of T2DM patients in various stages of CKD

    1 day

  • Frequency of T2DM patients with CKD in patients with different duration of T2DM

    1 day

  • Frequency of patients with HbA1C less than 7% in T2DM patients with and without CKD

    1 day

Study Arms (1)

T2DM patients with Chronic Kidney Disease

T2DM patients with Chronic Kidney Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 3000 T2DM patients of either gender with age of 18 years and more will be enrolled in the study after the Informed Consent Process.

You may qualify if:

  • Known cases of T2DM.
  • Male and female patients aged 18 years and above.
  • Must provide written Informed consent.

You may not qualify if:

  • Patients with known type-1 diabetes.
  • Patients with any form of acute kidney injury based on investigator's discretion.
  • Patients on maintenance dialysis or known renal transplant patients.
  • Patients who have participated in any interventional study within past 3 months prior to entry in this study.
  • Pregnant women.
  • Patients with symptomatic Urinary Tract Infection (UTI) or with history of hematuria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Research Site

Ahmedabad, India

Location

Research Site

Bangalore, India

Location

Research Site

Chandigarh, India

Location

Research Site

Chennai, India

Location

Research Site

Coimbatore, India

Location

Research Site

Delhi, India

Location

Research Site

Ghaziabad, India

Location

Research Site

Hyderabad, India

Location

Research Site

Jaipur, India

Location

Research Site

Kanpur, India

Location

Research Site

Karnāl, India

Location

Research Site

Kolkata, India

Location

Research Site

Ludhiana, India

Location

Research Site

Mumbai, India

Location

Research Site

Noida, India

Location

Research Site

Pune, India

Location

Research Site

Rohtak, India

Location

Research Site

Trivandrum, India

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dr. Prasanna Kumar K.M, DM

    Endocrinology Center for Diabetes and Endocrine Care

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 5, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 25, 2016

Record last verified: 2016-03

Locations

IN(18)