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

NCT ID: NCT06706609

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

394 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Getz Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Dr Shaheryar Hasan, MBBS, MBA

Role: CONTACT

+923121260642

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

Role: CONTACT

+923201212945

References

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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.

Reference Type BACKGROUND
PMID: 9839117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34110439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32893854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32819978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29503172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32816869 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/books/NBK581940/

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.

Other Identifiers

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GTZ-DM-008-24

Identifier Type: -

Identifier Source: org_study_id

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