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

Not yet recruiting

• Conditions: Diabetes Mellitus; Diabetes Mellitus, Adult-Onset; Diabetes Mellitus Type 1 and 2

• Registration Number: NCT06706609
• Lead Sponsor: Getz Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Study Start: 2025-02-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 394

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Analyze the distribution of metabolic and demographic characteristics within each cluster.	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	At the time of clinic visit during enrollment
Evaluate the relationship between clustering variables and complications.	At the time of clinic visit during enrollment