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

Sponsor

David Sanchez Garcia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05467514

Collaborator

Instituto Mexicano del Seguro Social (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Drug: Liraglutide	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 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

Arm

Intervention/Treatment

Experimental: 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

Drug: 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

Outcome Measures

Primary Outcome Measures

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

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]
Somatometry: weight will be measured at baseline and every month until completing 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]
Somatometry: Body mass index will be measured at baseline and every month until completing 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]
Somatometry: abdominal circumference will be measured at baseline and every month until completing 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]
Laboratory studies will be taken: complete lipid profile (total cholesterol, LDL, HDL, triglycerides, non-HDL cholesterol) at baseline, 3 and 6 months.
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (HbA1c) [0, 3 and 6 months]
Laboratory studies will be taken: HbA1c at baseline, 3 and 6 months.
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. eGDR [0, 3 and 6 months]
Estimated glucose disposal rate will be calculated at baseline, 3 and 6 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, MODY, 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 inhibitor, Pramlintide, metformin)
Start of treatment with statins, ezetimibe or PSCK9 inhibitors, amlodipine, metoprolol in the last 6 months before the study.
Bariatric surgery
Use of medications (immunosuppressants, calcineurin inhibitors, mTOR inhibitors, corticosteroids, aspirin, or anticoagulants)
Metabolic abnormalities (inborn errors of cholesterol storage metabolism, glycogen storage, abetalipoproteinemia, Reye's disease, LCAT deficiency)