Classification of Adult-onset Diabetes in Five Subgroups in Pakistani Population

November 22, 2024 updated by: Getz Pharma
This study aims to classify adult-onset diabetes patients into distinct data-driven clusters, such as severe insulin-deficient, severe insulin-resistant, mild obesity-related, and mild age-related diabetes, based on clinical and biochemical characteristics. Using a cross-sectional design, data will be collected from individuals attending outpatient diabetes clinics at tertiary care hospitals in Pakistan. The study will analyze the distribution of metabolic and demographic characteristics within each cluster and assess subgroup-specific risks for diabetic complications. Additionally, the relationship between clustering variables and the risk of complications will be evaluated to enhance the understanding of diabetes heterogeneity and its impact on patient outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

394

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adult patients diagnosed with diabetes who are receiving care at endocrinology clinics across Pakistan. Participants will be recruited from outpatient diabetes clinics during their routine visits. The population represents a diverse group of individuals from various socioeconomic and demographic backgrounds, reflecting the heterogeneity of diabetes presentation in the region

Description

Inclusion Criteria:

  • Patients of both genders whose age of disease onset was older than 16 years
  • Patients newly diagnosed with or previously diagnosed with T2D
  • Able and willing to provide written informed consent and to comply with the study

Exclusion Criteria:

  • Patients with other medical comorbidities (not a complication of diabetes), such as malignancies.
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Classify patients into data-driven clusters (e.g., severe insulin-deficient, severe insulin-resistant, mild obesity-related and mild age-related diabetes).
Time Frame: At the time of clinic visit during enrollment
At the time of clinic visit during enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Analyze the distribution of metabolic and demographic characteristics within each cluster.
Time Frame: At the time of clinic visit during enrollment
At the time of clinic visit during enrollment
• Assess subgroup-specific risks for diabetic macrovascular complications such as CVD, Stroke/TIA, and microvascular complications such as nephropathy, retinopathy, peripheral and autonomic neuropathy
Time Frame: At the time of clinic visit during enrollment
At the time of clinic visit during enrollment
Evaluate the relationship between clustering variables and complications.
Time Frame: At the time of clinic visit during enrollment
At the time of clinic visit during enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Getz Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTZ-DM-008-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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