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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05503303
Other study ID # T1D-DACS2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date March 1, 2022

Study information

Verified date August 2022
Source Universidad Juárez Autónoma de Tabasco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with type 1 diabetes (T1D) and metabolic syndrome (MS) require high doses of insulin to achieve a glycemic control, due to insulin resistance (IR). The investigators identified the presence of metabolic syndrome and insulin resistance in patients with T1D in a population of southeast Mexico. The sampled population was recruited from the Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo A. Rovirosa Pérez"; from August 2021 to February 2022, graduated physicians interviewed patients previously diagnosed with T1D. This study included patients older than 18 years and at least six months after being diagnosed with T1D. The interviewers excluded patients who did not attend regular consultations and those who did not agree to participate or to give a blood sample. A diabetologist evaluated and diagnosed all patients based on the World Health Organization (WHO) criteria. Fasting glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols were determined in blood serum using a Clinical Chemistry System from Random Access Diagnostics. The reasearch team determined glycated hemoglobin concentrations by an enzymatic immunoassay method.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date March 1, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - At least six months after being diagnosed with T1D Exclusion Criteria: - Did not attend regular consultations - Did not agree to participate or to give a blood sample

Study Design


Locations

Country Name City State
Mexico Isela Esther Juarez Rojop Villahermosa Tabasco

Sponsors (1)

Lead Sponsor Collaborator
Universidad Juárez Autónoma de Tabasco

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycated hemoglobin Concentrations by an enzymatic immunoassay method March 2022
Primary Total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols Determined in blood serum using a Clinical Chemistry System from Random Access Diagnostics March 2022
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