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Effects of Liraglutide on Glycemia, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients

Sponsor
University of Palermo (Other)
Overall Status
Completed
CT.gov ID
NCT05360537
Collaborator
(none)
135
Enrollment
1
Location
3
Arms
12.6
Actual Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to evaluate the effects of Liraglutide on glycemic control, serum markers of inflammation, markers of endothelial dysfunction and a possible correlation with intra and extra-hospital mortality rates in a group of hospitalized diabetic patients compared to a control group of in-patient diabetic in treatment on insulin Basal-bolus.

Condition or Disease Intervention/Treatment Phase
  • Drug: Liraglutide injection
  • Drug: Insulin Glargine
 Phase 4

Detailed Description

135 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke care ward of the University hospital of Palermo "P. Giaccone" from April 2022 to April 2023. 45 patients were treated with liraglutide, 45 were treated with liraglutide plus Basal Insulin and 45 were undertaken treatment regime with Insulin Basal Bolus (control group).

The study was carried out in accordance with the principles of the Helsinki Declaration revised in 2001 and all patients gave their written consent to take part in this research.

Each patient treated was compared for age, sex and cardiovascular risk with control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria of the American Diabetes Association (ADA), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria. Dyslipidemia was defined based on total cholesterol levels> 200 mg/dl, triglycerides> 150 mg/dl and HDL levels <40 mg/dl regardless of the patient's gender.

Among the cases enrolled, 135 (100%) had type 2 diabetes mellitus, 110 (80 %) had arterial hypertension and 74 (55%) hypercholesterolemia.

Clinical and anthropometric data were collected at the time of recruitment. Blood samples were taken from each patient (cases and controls) to determine serum glucose, HbA1c, CRP, Ferritin, IL-6. These withdrawals were then repeated three months and six months from the time of recruitment.

The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000.

Study Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Double (Participant, Care Provider)
Masking Description:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Effects of Liraglutide on Glycemic Control, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Apr 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: patients treated with liraglutide

Diabetes therapy with liraglutide and various combinations of metformin, repaglinide, sulfonylureas.

Drug: Liraglutide injection
administration of liraglutide
Other Names:
  • Liraglutide

    		•
    Experimental: patients treated with liraglutide plus Basal Insulin

    Diabetes therapy with liraglutide and various combinations of glargine insulin, metformin, repaglinide, sulfonylureas.

    Drug: Liraglutide injection
    administration of liraglutide
    Other Names:
  • Liraglutide

    • Drug: Insulin Glargine
    Administration of glargine insulin
    Other Names:
  • glargine

    		•
    Active Comparator: patients treated with Insulin regime Basal Bolus

    Diabetes therapy with the combination of a single administration of glargine insulin and three administration of Aspart Insulin.

    Drug: Insulin Glargine
    Administration of glargine insulin
    Other Names:
  • glargine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of average glycemia (mg/dl) at 3 and 6 months [0 months, 3 months and 6 months]

      Blodd sampling for the valutation of average glycemia (mg/dl)

    2. Change of hypoglycemic events [0 months, 3 months and 6 months]

      Change of hypoglycemic events (symptoms and serum glycemia < 60 mg/dl)

    3. Change from Baseline Reactive Hyperemia Index at 3 and 9 months [0 months, 3 months and 6 months]

      Change of Endothelial function by the use of Endopat2000 with the evaluation of Reactive Hypereremia Index (normal value of RHI > 1,27)

    Secondary Outcome Measures

    1. Change from Baseline serum of C- Reactive-Protein (CRP) [0 months, 3 months and 6 months]

      Variation from baseline serum levels of C- Reactive-Protein (CRP) (mg/dl)

    2. Change from Baseline serum levels of Interleukin-6 (IL6) [0 months, 3 months and 6 months]

      Variation from baseline serum levels of Interleukin-6 (IL6) (pg/ml)

    3. Change from Baseline serum levels of ferritin [0 months, 3 months and 6 months]

      Variation from baseline serum levels of ferritin (mcg/L)

    4. Change of intra and extra-hospital mortality [0 months, 3 months and 6 months]

      Change of intra and extra-hospital mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diabetes mellitus type 2

    • Mild-moderate Hyperglycemia (180-400 mg/dl)

    • Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU)

    Exclusion Criteria:

    • Diabetes mellitus type 1

    • Diabetic ketoacidosis

    • Hyperosmolar coma

    • Severe hypoglycaemia

    • Acute Pancreatitis

    • Cancer

    • use of corticosteroids

    • pregnancy

    • Chronic kidney disease (< 30 ml/min) or hemodialysis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Internal Medicine Ward, University of Palermo Palermo Italy 90127

    Sponsors and Collaborators

    • University of Palermo

    Investigators

    • Study Director: Antonino Tuttolomondo, Professor, University of Palermo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Antonino Tuttolomondo, University professor, University of Palermo
    ClinicalTrials.gov Identifier:
    NCT05360537
    Other Study ID Numbers:
    • U Palermo
    First Posted:
    May 4, 2022
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Antonino Tuttolomondo, University professor, University of Palermo
    liraglutide
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Inflammation
    Insulin Glargine
    Liraglutide

    Study Results

    No Results Posted as of May 4, 2022