NCT07574138

Brief Summary

  • Research objectives: Evaluate and compare the clinical and paraclinical characteristics, complications, as well as the changes in beta cell function and HbA1C levels between two patient groups over a one-year follow-up period. +Research design: This is a prospective cohort study, monitoring patients at 3, 6, 9, and 12 months.
  • Study Population and Sample Size: The study is planned to be conducted on 296 Vietnamese patients (accounting for a 20% dropout rate) who are being examined at the University of Medicine and Pharmacy Hospital in Ho Chi Minh City.
  • Key Evaluation Indicators: The function of beta cells and insulin resistance status are measured through the indices of HOMA-B, HOMA-IR, fasting C-peptide levels, and HbA1C levels.
  • Time and location: The study will be conducted from February 2025 to February 2028 at the Endocrinology Clinic, University Medical Center Ho Chi Minh City.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Feb 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Feb 2025Feb 2028

Study Start

First participant enrolled

February 24, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Type 2 Diabetes Mellitus (T2DM)Beta Cell Function

Keywords

Early-onset type 2 diabetes mellitusBeta cell functionC-peptide

Outcome Measures

Primary Outcomes (2)

  • Changes in fasting blood C-peptide concentration

    Measurement of C-peptide concentration in venous blood (unit: nmol/L) using chemiluminescent immunoassay

    At baseline (T0), 6 months (T6), and 12 months (T12)

  • Beta Cell Function Index (HOMA-B)

    A mathematical model index (unit: %) is calculated based on fasting glucose and insulin/C-peptide concentrations. The formula is: HOMA-B = 20 x Fasting Insulin (µU/ml) / \[Fasting Glucose (mmol/L) - 3.5\]

    At baseline (T0), 6 months (T6), and 12 months (T12)

Secondary Outcomes (3)

  • Insulin resistance status (HOMA-IR)

    At baseline (T0), 6 months (T6), and 12 months (T12)

  • The ability to regulate blood glucose levels through the HbA1C index

    At regular intervals at time points T0, 3 months, 6 months, 9 months, and 12 months

  • The incidence or progression of chronic complications

    Record at time points T0, 6 months, and 12 months

Study Arms (2)

Early onset type 2 diabetes mellitus

Includes patients diagnosed with type 2 diabetes mellitus according to the ADA 2024 criteria with an onset age of under 40 years

Other: Monitor and observe the clinical progression and beta cell function

Type 2 diabetes mellitus typically presents

Includes patients diagnosed with type 2 diabetes mellitus according to the ADA 2024 criteria, with an onset age of 40 years or older

Other: Monitor and observe the clinical progression and beta cell function

Interventions

Monitor and observe the clinical progression and beta cell functionOTHER

Monitor and observe the clinical progression and beta cell function

Early onset type 2 diabetes mellitusType 2 diabetes mellitus typically presents

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A patient with type 2 diabetes mellitus presents for evaluation at the Endocrinology clinic of the University Medical Center of Ho Chi Minh City.

You may qualify if:

  • The patient is diagnosed with Type 2 Diabetes Mellitus according to the ADA 2024 criteria (Fasting Glucose ≥ 126 mg/dl, or Glucose after 2 hours of an Oral Glucose Tolerance Test ≥ 200 mg/dl, or HbA1C ≥ 6.5%, or with typical symptoms accompanied by any Glucose ≥ 200 mg/dl).
  • The duration of Type 2 Diabetes Mellitus does not exceed 10 years.
  • Classification by age of onset: Early onset group (\< 40 years) and typical onset group (≥ 40 years).
  • At least 6 months without the need for insulin and no recorded episodes of diabetic ketoacidosis since the time of diagnosis.
  • For the early-onset group: Autoantibodies (Anti-GAD, ICA) are negative and fasting C-peptide levels are \> 0.6 nmol/L.
  • The patient consents to participate in the study and signs the informed consent document.

You may not qualify if:

  • Pregnant women or patients with acute illnesses at the time of assessment.
  • The patient has been diagnosed with or exhibits characteristics suggestive of Type 1 Diabetes Mellitus (such as a history of ketoacidosis, C-peptide \< 0.2 nmol/L).
  • Secondary diabetes mellitus due to pancreatic disorders (pancreatitis, pancreatic tumors, pancreatic resection), due to medications (glucocorticoids), or due to other endocrine disorders (Cushing's syndrome, hyperthyroidism, acromegaly).
  • Severe renal failure with an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m².
  • Use of medications that affect beta cell function or complications such as prolonged high-dose corticosteroids, immunosuppressive agents, or chemotherapy.
  • Not of Vietnamese ethnicity.
  • Non-compliance with treatment guidelines or failure to attend scheduled follow-up appointments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medicine and Pharmacy of Ho Chi Minh City

Ho Chi Minh City, Cho Lon Ward, 72700, Vietnam

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples were collected for biochemical tests (glucose, HbA1C, creatinine, lipid profile), immunological tests (C-peptide, insulin, anti-GAD antibodies, ICA), and for the storage of blood samples and DNA samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Chi Khanh Hoang, Specialist physician level 1

    University of Medicine and Pharmacy of Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

  • Nam Quang Tran, Associate professor - Doctorat

    University of Medicine and Pharmacy of Ho Chi Minh City

    STUDY DIRECTOR

  • Tran Viet Thang, Doctorate

    University of Medicine and Pharmacy of Ho Chi Minh City

    STUDY DIRECTOR

Central Study Contacts

Chi Khanh Hoang, Specialist physician level 1

CONTACT

84985578494chi.hk@umc.edu.vn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 7, 2026

Study Start

February 24, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

May 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)