NCT05939869

Brief Summary

The Investigators are recruiting T2DM patients (n, 500) from Fortis-CDOC Hospital. Patients' weight, BMI, lipid profile, liver and kidney function tests, EGG, glycemic parameters, blood pressure, etc. will be entered in MS Excel sheets and appropriate data coding will be performed. Additional information on sleep hygiene, self-perceived stress, environmental pollution, and socio-economic status (education, occupation, and family annual income) will be collected by phone interviews. The entered data will be filtered for outliers and missing data will be excluded from the final data sheet. Johns Hopkins Team will perform the following:

  • During the initial three months of the study, the plan is to obtain all requisite permissions for data gathering from the Institutional Ethics Review Committees of the respective institutions. The research assistant would be recruited from FORTIS-CDOC Hospital.
  • Over the next 12 months, there will be data tabulation and gathering
  • The last 3-4 months will be allocated to data analysis, application of AI algorithms (using training and testing datasets), and reporting of the data (meetings and manuscripts)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

July 3, 2023

Last Update Submit

July 11, 2023

Conditions

Keywords

Type 2 DiabetesAsian IndianCVD

Outcome Measures

Primary Outcomes (1)

  • Risk of CVD Event

    How many T2DM patients will get MI or Stroke within next five years.

    5 years

Interventions

Retrospective and prospective analysis of patients data will be done.

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Urban Indian Population with minimum duration of 5 years of T2DM.

You may qualify if:

  • \- T2DM

You may not qualify if:

  • T1DM
  • Genetic Diabetes
  • Gestational Diabetes
  • Terminal Illness (Cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortis Cdoc Hospital

New Delhi, National Capital Territory of Delhi, 110048, India

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

ANOOP MISRA, MD

CONTACT

IRSHAD AHMAD, M.Sc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 11, 2023

Study Start

July 1, 2023

Primary Completion

July 31, 2024

Study Completion

August 30, 2024

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations