Latent Autoimmune DiabetesLADA patientsNCT05235672
Detection of LADA in a Hospital in the Mexican Southeast
An observational study of Latent Autoimmune Diabetes, run by Universidad Juárez Autónoma de Tabasco at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Latent Autoimmune Diabetes
- How many people
- 110 participants
- Where
- 1 siteMexico
- Study dates
- 30 Jan 2021to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- patients with other types of diabetes, and subjects who did not agree to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
GADA in serum of subjects with T2D
Serum GADA concentrations were determined by an enzymatic immunoassay method in subjects with T2D
Measured: May 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start30 Jan 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Autoimmune DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Juárez Autónoma de Tabasco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ISELA ESTHER JUAREZ-ROJOP Ph.D., Universidad Juárez Autónoma de Tabasco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235672
- Sponsor's protocol ID
- LADA-DACS
- Acronym
- LADA patients
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05235672
- Acronym / sponsor ID
- LADA patients / LADA-DACS
- Conditions
- Latent Autoimmune Diabetes
- Keywords
- LADA, GADA, Mexican population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universidad Juárez Autónoma de TabascoUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- patients with other types of diabetes, and subjects who did not agree to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Latent Autoimmune Diabetes, run by Universidad Juárez Autónoma de Tabasco at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GADA in serum of subjects with T2D (time frame: May 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.