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临床试验/NCT05235672
NCT05235672已完成不适用

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.

Universidad Juárez Autónoma de Tabasco1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
GADA in serum of subjects with T2D

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • patients with other types of diabetes, and subjects who did not agree to participate.

结局指标

主要结局

GADA in serum of subjects with T2D

时间窗: May 2021

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ISELA ESTHER JUAREZ-ROJOP Ph.D.

Professor

Universidad Juárez Autónoma de Tabasco

研究点 (1)

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