Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus
- Registration Number
- NCT05467514
- Lead Sponsor
- David Sanchez Garcia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Liraglutide 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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: 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 (Estimated glucose disposal rate) 0, 3 and 6 months Estimated glucose disposal rate will be calculated at baseline, 3 and 6 months.
Trial Locations
- Locations (1)
Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25
🇲🇽Monterrey, Nuevo León, Mexico
Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25🇲🇽Monterrey, Nuevo León, Mexico