Type 1 DiabetesNCT05503303
T1D, Metabolic Syndrome and Insulin Resistance
An observational study of Type 1 Diabetes and Metabolic Syndrome, run by Universidad Juárez Autónoma de Tabasco at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 1 Diabetes, Metabolic Syndrome, Insulin Resistance
- How many people
- 19 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2021to 1 Mar 2022
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- At least six months after being diagnosed with T1D
Who cannot join
- Did not attend regular consultations
- Did not agree to participate or to give a blood sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Characteristics in Adults With Type 1 Diabetes, Metabolic Syndrome and Insulin Resistance
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.
- Conditions
- Type 1 Diabetes, Metabolic Syndrome, Insulin Resistance
- Medical subject headings
- Diabetes Mellitus, Type 1, Metabolic Syndrome, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
Concentrations by an enzymatic immunoassay method
Measured: March 2022
Total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols
Determined in blood serum using a Clinical Chemistry System from Random Access Diagnostics
Measured: March 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Aug 2021
- Primary completion15 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 19 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
- NCT05503303
- Sponsor's protocol ID
- T1D-DACS2022
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2022
- Last updated
- 19 Aug 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 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics in Adults With Type 1 Diabetes, Metabolic Syndrome and Insulin Resistance
- ClinicalTrials.gov ID
- NCT05503303
- Acronym / sponsor ID
- T1D-DACS2022
- Conditions
- Type 1 Diabetes, Metabolic Syndrome, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidad Juárez Autónoma de TabascoUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 16 Aug 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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- At least six months after being diagnosed with T1D
Key exclusion criteria (2 listed)
- Did not attend regular consultations
- Did not agree to participate or to give a blood sample
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
Glycated hemoglobin
Time frame: March 2022
Concentrations by an enzymatic immunoassay method
Total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols
Time frame: March 2022
Determined in blood serum using a Clinical Chemistry System from Random Access Diagnostics
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 19 Aug 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 Type 1 Diabetes and Metabolic Syndrome, 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 1 inclusion and 2 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 19 Aug 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?
Glycated hemoglobin (time frame: March 2022). The study lists 2 primary outcomes in all. 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 19 Aug 2022.