Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus

NCT ID: NCT05467514

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-02-28

Brief Summary

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The aim of the trail is investigate the effect of liraglutide 1.8mg as add-on to insulin for 6 months on carotid intima media thickness and cardiovascular risk factors in subjects with type 1 diabetes mellitus.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Application of liraglutide 1.8 mg subcutaneous daily for 6 months to evaluate subclinical atherosclerosis, by means of carotid doppler US, lipid profile in patients with type 1 diabetes mellitus
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liraglutide

Application of liraglutide 1.8 mg subcutaneous daily for 6 months to evaluate subclinical atherosclerosis, by means of carotid doppler US, lipid profile in patients with type 1 diabetes mellitus

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

Application of liraglutide 1.8 mg subcutaneous daily for 6 months to evaluate subclinical atherosclerosis, by means of carotid doppler US, lipid profile in patients with type 1 diabetes mellitus

Interventions

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Liraglutide

Application of liraglutide 1.8 mg subcutaneous daily for 6 months to evaluate subclinical atherosclerosis, by means of carotid doppler US, lipid profile in patients with type 1 diabetes mellitus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age from 15 to 60 years
* Patients diagnosed with Type 1 Diabetes Mellitus.
* Diabetes duration more than 1 year.
* Both genders.
* C - peptide less than 0.3 nmol/L

Exclusion Criteria

* Patients with type 2 diabetes mellitus, LADA (latent autoimmune diabetes in adults), MODY (maturity-onset diabetes of youth), or other types of diabetes other than type 1 diabetes mellitus.
* Pregnant patients or desire to become pregnant in the next 6 months.
* Family history of medullary thyroid cancer or multiple endocrine neoplasia 2
* History of pancreatitis
* Familial hypercholesterolemia
* Use of adjunctive treatment to insulin (SGLT-2 \[sodium-glucose cotransporter-2\] inhibitor, Pramlintide, metformin)
* Start of treatment with statins, ezetimibe or PSCK9 (proprotein convertase subtilisin/kexin type 9) inhibitors, amlodipine, metoprolol in the last 6 months before the study.
* Bariatric surgery
* Use of medications (immunosuppressants, calcineurin inhibitors, mTOR (mammilian target of rapamycin) inhibitors, corticosteroids, aspirin, or anticoagulants)
* Metabolic abnormalities (inborn errors of cholesterol storage metabolism, glycogen storage, abetalipoproteinemia, Reye's disease, LCAT (lecithin-cholesterol acyltransferase) deficiency)
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role collaborator

David Sanchez Garcia

OTHER_GOV

Sponsor Role lead

Responsible Party

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David Sanchez Garcia

Principal Investigator David Sanchez Garcia

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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F-2022-1901-019

Identifier Type: -

Identifier Source: org_study_id

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