NCT05503303

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

August 13, 2022

Last Update Submit

August 16, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Glycated hemoglobin

    Concentrations by an enzymatic immunoassay method

    March 2022

  • Total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols

    Determined in blood serum using a Clinical Chemistry System from Random Access Diagnostics

    March 2022

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who attend Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo A. Rovirosa Pérez", previously diagnosed with type 1 diabetes

You may qualify if:

  • At least six months after being diagnosed with T1D

You may not qualify if:

  • Did not attend regular consultations
  • Did not agree to participate or to give a blood sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isela Esther Juarez Rojop

Villahermosa, Tabasco, 86090, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Metabolic SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full-Time Investigator Professor

Study Record Dates

First Submitted

August 13, 2022

First Posted

August 16, 2022

Study Start

August 1, 2021

Primary Completion

February 15, 2022

Study Completion

March 1, 2022

Last Updated

August 19, 2022

Record last verified: 2022-08

Locations