Detection of LADA in a Hospital in the Mexican Southeast (LADA patients)

February 10, 2022 updated by: ISELA ESTHER JUAREZ-ROJOP Ph.D., Universidad Juárez Autónoma de Tabasco

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.

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Tabasco
      • Villahermosa, Tabasco, Mexico, 86090
        • Isela Esther Juarez Rojop

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
May 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Juárez Autónoma de Tabasco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LADA-DACS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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