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

David Sanchez Garcia35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

LiraglutideDRUG

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

Eligibility

Sex: ALLMin age: 15 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

Locations (1)

Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25

Monterrey, Nuevo León, Mexico

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline and 6 months

Secondary Outcomes

To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers (BMI, weight and abdominal circumference)

Somatometry: weight will be measured at baseline and every month until completing 6 months.

Time frame: 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)

Somatometry: Body mass index will be measured at baseline and every month until completing 6 months.

Time frame: 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)

Somatometry: abdominal circumference will be measured at baseline and every month until completing 6 months.

Time frame: 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)

Laboratory studies will be taken: complete lipid profile (total cholesterol, LDL, HDL, triglycerides, non-HDL cholesterol) at baseline, 3 and 6 months.

Time frame: 0, 3 and 6 months

To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (HbA1c)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.