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OpenTrials
Completed

NCT Number: NCT05235672

Detection of LADA in a Hospital in the Mexican Southeast

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).

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Isela Esther Juarez Rojop

Villahermosa, Tabasco, 86090, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. GADA in serum of subjects with T2D

    Time frame: May 2021

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

Sponsors and collaborators

Lead sponsor

Universidad Juárez Autónoma de Tabasco

Other

Registry information

Official study title

Detection of Latent Autoimmune Diabetes in Adults, Clinical and Metabolic Profile in Patients Treated at the Diabetes Clinic in a Hospital in the Mexican Southeast.

Acronym: LADA patients

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2022
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.