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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Sanchez Garcia
• Collaborator: Instituto Mexicano del Seguro Social
• Treatments: Liraglutide

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, 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)