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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Liraglutide
Sponsored by
David Sanchez Garcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Liraglutide, Diabetes Mellitus, Type 1, Atherosclerosis

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liraglutide

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 7, 2022
Last Updated
February 28, 2023
Sponsor
David Sanchez Garcia
Collaborators
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT05467514
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Sanchez Garcia
Collaborators
Instituto Mexicano del Seguro Social

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Liraglutide, Diabetes Mellitus, Type 1, Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention 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 Outcome Measure Information:
Title
To assess the effect of liraglutide on carotid intima media thickness in patients with type 1 diabetes mellitus.
Description
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.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers (BMI, weight and abdominal circumference)
Description
Somatometry: weight will be measured at baseline and every month until completing 6 months.
Time Frame
0, 1, 2, 3, 4, 5 and 6 months
Title
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. Somatometry (BMI, weight and abdominal circumference)
Description
Somatometry: Body mass index will be measured at baseline and every month until completing 6 months.
Time Frame
0, 1, 2, 3, 4, 5 and 6 months
Title
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. Somatometry (BMI, weight and abdominal circumference)
Description
Somatometry: abdominal circumference will be measured at baseline and every month until completing 6 months.
Time Frame
0, 1, 2, 3, 4, 5 and 6 months
Title
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (total cholesterol, LDL, HDL, triglycerides, non-HDL cholesterol)
Description
Laboratory studies will be taken: complete lipid profile (total cholesterol, LDL, HDL, triglycerides, non-HDL cholesterol) at baseline, 3 and 6 months.
Time Frame
0, 3 and 6 months
Title
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (HbA1c)
Description
Laboratory studies will be taken: HbA1c at baseline, 3 and 6 months.
Time Frame
0, 3 and 6 months
Title
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. eGDR (Estimated glucose disposal rate)
Description
Estimated glucose disposal rate will be calculated at baseline, 3 and 6 months.
Time Frame
0, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25
City
Monterrey
State/Province
Nuevo León
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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