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

NCT06706609 | Not Yet Recruiting

• 1 other identifier: GTZ-DM-008-24
• Study Type: observational
• Target: 394
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Adult-Onset; Diabetes Mellitus Type 1 and 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Getz Pharma: lead

Related Publications (6)

• Levy JC, Matthews DR, Hermans MP. Correct homeostasis model assessment (HOMA) evaluation uses the computer program. Diabetes Care. 1998 Dec;21(12):2191-2. doi: 10.2337/diacare.21.12.2191. No abstract available.

  PMID: 9839117 BACKGROUND

• Slieker RC, Donnelly LA, Fitipaldi H, Bouland GA, Giordano GN, Akerlund M, Gerl MJ, Ahlqvist E, Ali A, Dragan I, Festa A, Hansen MK, Mansour Aly D, Kim M, Kuznetsov D, Mehl F, Klose C, Simons K, Pavo I, Pullen TJ, Suvitaival T, Wretlind A, Rossing P, Lyssenko V, Legido-Quigley C, Groop L, Thorens B, Franks PW, Ibberson M, Rutter GA, Beulens JWJ, 't Hart LM, Pearson ER. Replication and cross-validation of type 2 diabetes subtypes based on clinical variables: an IMI-RHAPSODY study. Diabetologia. 2021 Sep;64(9):1982-1989. doi: 10.1007/s00125-021-05490-8. Epub 2021 Jun 10.

  PMID: 34110439 BACKGROUND

• Li PF, Chen WL. Are the Different Diabetes Subgroups Correlated With All-Cause, Cancer-Related, and Cardiovascular-Related Mortality? J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa628. doi: 10.1210/clinem/dgaa628.

  PMID: 32893854 BACKGROUND

• Bonora E, Trombetta M, Dauriz M, Travia D, Cacciatori V, Brangani C, Negri C, Perrone F, Pichiri I, Stoico V, Zoppini G, Rinaldi E, Da Prato G, Boselli ML, Santi L, Moschetta F, Zardini M, Bonadonna RC. Chronic complications in patients with newly diagnosed type 2 diabetes: prevalence and related metabolic and clinical features: the Verona Newly Diagnosed Type 2 Diabetes Study (VNDS) 9. BMJ Open Diabetes Res Care. 2020 Aug;8(1):e001549. doi: 10.1136/bmjdrc-2020-001549.

  PMID: 32819978 BACKGROUND

• Ahlqvist E, Storm P, Karajamaki A, Martinell M, Dorkhan M, Carlsson A, Vikman P, Prasad RB, Aly DM, Almgren P, Wessman Y, Shaat N, Spegel P, Mulder H, Lindholm E, Melander O, Hansson O, Malmqvist U, Lernmark A, Lahti K, Forsen T, Tuomi T, Rosengren AH, Groop L. Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables. Lancet Diabetes Endocrinol. 2018 May;6(5):361-369. doi: 10.1016/S2213-8587(18)30051-2. Epub 2018 Mar 5.

  PMID: 29503172 BACKGROUND

• Anjana RM, Baskar V, Nair ATN, Jebarani S, Siddiqui MK, Pradeepa R, Unnikrishnan R, Palmer C, Pearson E, Mohan V. Novel subgroups of type 2 diabetes and their association with microvascular outcomes in an Asian Indian population: a data-driven cluster analysis: the INSPIRED study. BMJ Open Diabetes Res Care. 2020 Aug;8(1):e001506. doi: 10.1136/bmjdrc-2020-001506.

  PMID: 32816869 BACKGROUND

Related Links

• Sample Size Calculator
• Magliano DJ, Boyko EJ; IDF Diabetes Atlas 10th edition scientific committee. IDF DIABETES ATLAS \[Internet\]. 10th edition. Brussels: International Diabetes Federation; 2021. Chapter 3, Global picture.

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Dr Shaheryar Hasan, MBBS, MBA

CONTACT

+923121260642; shaheryar.hasan@getzpharma.com

Dr Jahanzeb Kamal Khan, MBBS, MBA, CRCP, MCPS

CONTACT

+923201212945; jahanzeb.kamal@getzpharma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: February 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share