Detection of LADA in a Hospital in the Mexican Southeast

Completed

• Conditions: Latent Autoimmune Diabetes

• Registration Number: NCT05235672
• Lead Sponsor: Universidad Juárez Autónoma de Tabasco

Brief Summary

Patients with Latent Autoimmune Diabetes in Adults (LADA) show autoantibodies that indicate an autoimmune pathogenesis. Glutamic acid decarboxylase autoantibodies (GADA) are most prevalent islet autoantibodies in European patients with LADA. In this sense, it is considered that it is sufficient to determine GADA to identify subjects with LADA from patients with T2D for research purposes. Therefore, the aim was to investigated the presence of GADA in serum of subjects with T2D and its relationship with clinical criteria, metabolic control, drug treatment, and diabetes complications to identify possible patients with LADA in a hospital in southeastern Mexico is worthwhile.

The sample was recruited at the Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo A. Rovirosa Pérez", in the period from January 2020 to May 2021. The diagnosis was based in accordance with World Health Organization (WHO, 1999) criteria. Inclusion criteria: 1) patients previously diagnosed with T2D, 2) absence of insulin requirement for at least 6 months after diagnosis, 3) \> 30 and \< 50 years old at diabetes diagnosis, 4) BMI \< 40 kg/m2, 5) subjects who agreed to participate in the study and signed the informed consent before the interview.

Serum GADA and other biochemical concentrations were determined by an enzymatic immunoassay method (Human Anti-Glutamic Acid Decarboxylase ELISA Kit; MyBioSource).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-30
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Study First Submitted: 2022-01-25
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-10
• Last Update Submitted: 2022-02-10
• Study First Posted: 2022-02-11
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• patients previously diagnosed with T2D,
• absence of insulin requirement for at least 6 months after diagnosis,
• > 30 and < 50 years old at diabetes diagnosis,
• BMI < 40 kg/m2,
• subjects who agreed to participate in the study and signed the informed consent before the interview.

Exclusion Criteria

• patients with other types of diabetes, and subjects who did not agree to participate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GADA in serum of subjects with T2D	May 2021	Serum GADA concentrations were determined by an enzymatic immunoassay method in subjects with T2D

Trial Locations

Locations (1)

Isela Esther Juarez Rojop; 🇲🇽 Villahermosa, Tabasco, Mexico