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NCT Number: NCT05467514

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Autoimmune Diseases Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25

Monterrey, Nuevo León, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

liraglutide

Drug

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 outcomes

  1. To assess the effect of liraglutide on carotid intima media thickness in patients with type 1 diabetes mellitus.

    Time frame: 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 outcomes

  1. To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers (BMI, weight and abdominal circumference)

    Time frame: 0, 1, 2, 3, 4, 5 and 6 months

    Somatometry: weight will be measured at baseline and every month until completing 6 months.

  2. To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. Somatometry (BMI, weight and abdominal circumference)

    Time frame: 0, 1, 2, 3, 4, 5 and 6 months

    Somatometry: Body mass index will be measured at baseline and every month until completing 6 months.

  3. To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. Somatometry (BMI, weight and abdominal circumference)

    Time frame: 0, 1, 2, 3, 4, 5 and 6 months

    Somatometry: abdominal circumference will be measured at baseline and every month until completing 6 months.

  4. To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (total cholesterol, LDL, HDL, triglycerides, non-HDL cholesterol)

    Time frame: 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.

  5. To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (HbA1c)

    Time frame: 0, 3 and 6 months

    Laboratory studies will be taken: HbA1c at baseline, 3 and 6 months.

  6. To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. eGDR (Estimated glucose disposal rate)

    Time frame: 0, 3 and 6 months

    Estimated glucose disposal rate will be calculated at baseline, 3 and 6 months.

Sponsors and collaborators

Lead sponsor

David Sanchez Garcia

Other Gov

Collaborators

  • Instituto Mexicano del Seguro Social

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2022
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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