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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Liraglutide


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide<br>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 | Drug: Liraglutide<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 0, 3 and 6 months | 
| To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (HbA1c) | Laboratory studies will be taken: HbA1c at baseline, 3 and 6 months. | 0, 3 and 6 months | 
| To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. eGDR (Estimated glucose disposal rate) | Estimated glucose disposal rate will be calculated at baseline, 3 and 6 months. | 0, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liraglutide, Diabetes Mellitus, Type 1, Atherosclerosis