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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

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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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Juárez Autónoma de Tabasco

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

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January 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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