Detection of LADA in a Hospital in the Mexican Southeast

NCT05235672 | Completed

• 1 other identifier: LADA-DACS
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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).

Conditions

Latent Autoimmune Diabetes

Keywords

LADA; GADA; Mexican population

Outcome Measures

Primary Outcomes (1)

• GADA in serum of subjects with T2D

  Serum GADA concentrations were determined by an enzymatic immunoassay method in subjects with T2D

  May 2021

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects were initially diagnosed and received pharmacological treatment for T2D. In addition, these patients presented clinical and biochemical characteristics both of T1D and T2D, progressing to insulin dependency. Such individuals were invited to participate in the study. An endocrinologist diagnosed and evaluated all these patients.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Juárez Autónoma de Tabasco: lead

Study Sites (1)

Isela Esther Juarez Rojop

Villahermosa, Tabasco, 86090, Mexico

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 11, 2022
• Study Start: January 30, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

ME (1)