NCT05235672: LADA patients

Detection of LADA in a Hospital in the Mexican Southeast

Completed Last updated 11 February 2022

What this trial tests

trial in Latent Autoimmune Diabetes in 110 participants. Completed in 30 December 2021.

Timeline

30 January 2021

Primary endpoint
30 December 2021

30 December 2021

Quick facts

Lead sponsor	Universidad Juárez Autónoma de Tabasco
Status	Completed
Study type	OBSERVATIONAL
Enrollment	110
Start date	30 January 2021
Primary completion	30 December 2021
Estimated completion	30 December 2021
Sites	1 location across Mexico

Conditions studied

• Latent Autoimmune Diabetes — all drugs for Latent Autoimmune Diabetes →

Sponsor

Universidad Juárez Autónoma de Tabasco

Who can join

Adults 30 to 50, any sex, with Latent Autoimmune Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Telomere Shortening in Three Diabetes Mellitus Types in a Mexican Sample.
   Cuevas Diaz P, Nicolini H, Nolasco-Rosales GA, Juarez Rojop I, et al · · 2023 · cited 9× · PMID 36979709 · DOI 10.3390/biomedicines11030730
2. Identification and phenotypic characterization of patients with LADA in a population of southeast Mexico.
   Nolasco-Rosales GA, Ramírez-González D, Rodríguez-Sánchez E, Ávila-Fernandez Á, et al · · 2023 · cited 4× · PMID 37120620 · DOI 10.1038/s41598-023-34171-2