Clinical trial NCT06706609: Classification of Adult-onset Diabetes in Five Subgroups in Pakistani Population
Official title: Classification of Adult-onset Diabetes in Five Subgroups in Pakistani Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus
Diabetes Mellitus, Adult-Onset
Diabetes Mellitus Type 1 and 2
Lead sponsor: Getz Pharma
Sponsor class: INDUSTRY
First posted: 2024-11-26
Enrollment: 394
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Classify patients into data-driven clusters (e.g., severe insulin-deficient, severe insulin-resistant, mild obesity-related and mild age-related diabetes).
timeFrame: At the time of clinic visit during enrollment
Secondary outcomes:
measure: Analyze the distribution of metabolic and demographic characteristics within each cluster.
timeFrame: At the time of clinic visit during enrollment
measure: • Assess subgroup-specific risks for diabetic macrovascular complications such as CVD, Stroke/TIA, and microvascular complications such as nephropathy, retinopathy, peripheral and autonomic neuropathy
timeFrame: At the time of clinic visit during enrollment
measure: Evaluate the relationship between clustering variables and complications.
timeFrame: At the time of clinic visit during enrollment
Other outcomes:
Locations:
Study officials:
References:
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