Clinical trial NCT05467514: Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus
Official title: Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Keywords: Liraglutide
Diabetes Mellitus, Type 1
Atherosclerosis
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Mexicano del Seguro Social
First posted: 2022-07-20
Enrollment: 35
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

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.


Eligibility 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 (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)

Primary outcomes:
measure: To assess the effect of liraglutide on carotid intima media thickness in patients with type 1 diabetes mellitus.
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers (BMI, weight and abdominal circumference)
timeFrame: 0, 1, 2, 3, 4, 5 and 6 months
measure: To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. Somatometry (BMI, weight and abdominal circumference)
timeFrame: 0, 1, 2, 3, 4, 5 and 6 months
measure: To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. Somatometry (BMI, weight and abdominal circumference)
timeFrame: 0, 1, 2, 3, 4, 5 and 6 months
measure: To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (total cholesterol, LDL, HDL, triglycerides, non-HDL cholesterol)
timeFrame: 0, 3 and 6 months
measure: To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (HbA1c)
timeFrame: 0, 3 and 6 months
measure: To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. eGDR (Estimated glucose disposal rate)
timeFrame: 0, 3 and 6 months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25
state: Nuevo León
Study officials:
References: