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

David Sanchez Garcia1 site in 1 country35 target enrollmentJuly 1, 2022

ConditionsDiabetes Mellitus, Type 1

InterventionsLiraglutide

DrugsLiraglutide

Overview

Phase: Phase 3
Intervention: Liraglutide
Conditions: Diabetes Mellitus, Type 1
Sponsor: David Sanchez Garcia
Enrollment: 35
Locations: 1
Primary Endpoint: To assess the effect of liraglutide on carotid intima media thickness in patients with type 1 diabetes mellitus.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

February 28, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

David Sanchez Garcia

Responsible Party

Sponsor Investigator

Principal Investigator

David Sanchez Garcia

Principal Investigator David Sanchez Garcia

Instituto Mexicano del Seguro Social

Eligibility Criteria

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)

Arms & Interventions

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: Liraglutide

Outcomes

Primary Outcomes

To assess the effect of liraglutide on carotid intima media thickness in patients with type 1 diabetes mellitus.

Time Frame: Baseline and 6 months

Change from baseline measure of right carotid intima media thickness with doppler ultrasound at 6 months in patients with type 1 diabetes mellitus who meet inclusion criteria.

Secondary Outcomes

To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers (BMI, weight and abdominal circumference)(0, 1, 2, 3, 4, 5 and 6 months)
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. Somatometry (BMI, weight and abdominal circumference)(0, 1, 2, 3, 4, 5 and 6 months)
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (total cholesterol, LDL, HDL, triglycerides, non-HDL cholesterol)(0, 3 and 6 months)
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (HbA1c)(0, 3 and 6 months)
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. eGDR (Estimated glucose disposal rate)(0, 3 and 6 months)