ClinicalTrials.gg
Not yet recruitingNCT06706609Updated Nov 26, 2024

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

An observational study in Diabetes Mellitus, Diabetes Mellitus, Adult-Onset and Diabetes Mellitus Type 1 and 2, sponsored by Getz Pharma. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Getz Pharma · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
394
Ages
16 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Diabetes Mellitus
  • Diabetes Mellitus, Adult-Onset
  • Diabetes Mellitus Type 1 and 2
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's planned enrollment of 394 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Getz Pharma is the lead sponsor of 19 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and to comply with the study

Exclusion criteria

Exclusion Criteria:

  • Patients with other medical comorbidities (not a complication of diabetes), such as .
  • Pregnancy
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
394 participants (estimated)
Patient registry
No
06

What researchers measure

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).

    Time frame: At the time of clinic visit during enrollment

Secondary outcomes

  1. Analyze the distribution of metabolic and demographic characteristics within each cluster.

    Time frame: At the time of clinic visit during enrollment

  2. • 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

  3. Evaluate the relationship between clustering variables and complications.

    Time frame: At the time of clinic visit during enrollment

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 9839117 ↗
  • 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. PubMed 34110439 ↗
  • 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. PubMed 32893854 ↗
  • 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. PubMed 32819978 ↗
  • 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. PubMed 29503172 ↗
  • 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. PubMed 32816869 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2025; primary completion for Aug 2025, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2024
First posted
Nov 26, 2024
StartEst.
Feb 1, 2025
Primary completionEst.
Aug 1, 2025
CompletionEst.
Dec 31, 2025
Last update
Nov 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06706609
Lead sponsor
Getz Pharma
Responsible party
Sponsor
First posted
Nov 26, 2024
Start date
Feb 1, 2025 (estimated)
Primary completion
Aug 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Nov 26, 2024

Study contacts

Dr Shaheryar Hasan, MBBS, MBA
Contact
shaheryar.hasan@getzpharma.com
+923121260642
Dr Jahanzeb Kamal Khan, MBBS, MBA, CRCP, MCPS
Contact
jahanzeb.kamal@getzpharma.com
+923201212945

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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