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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05467514
• Other study ID #: F-2022-1901-019
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2023
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
Mexico	Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25	Monterrey	Nuevo León

Sponsors (2)

Lead Sponsor	Collaborator
David Sanchez Garcia	Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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