Effects of Degludec/Liraglutide on Time in Range, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients
NCT ID: NCT05360537
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2021-04-01
2022-04-20
Brief Summary
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Detailed Description
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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 glycemic variability was assessed by continuous glycemic monitoring with the analysis of Time in Range
The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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patients treated with Insulin Degludec/Liraglutide
Diabetes therapy with Insulin Degludec/Liraglutide and various combinations of metformin, repaglinide, sulfonylureas.
Insulin Degludec / Liraglutide Injectable Product
administration of Insulin Degludec/Liraglutide
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.
Insulin Glargine
Administration of glargine insulin
Interventions
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Insulin Degludec / Liraglutide Injectable Product
administration of Insulin Degludec/Liraglutide
Insulin Glargine
Administration of glargine insulin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mild-moderate Hyperglycemia (180-400 mg/dl)
* Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU)
Exclusion Criteria
* Diabetic ketoacidosis
* Hyperosmolar coma
* Severe hypoglycaemia
* Acute Pancreatitis
* Cancer
* use of corticosteroids
* pregnancy
* Chronic kidney disease (\< 30 ml/min) or hemodialysis
18 Years
90 Years
ALL
No
Sponsors
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University of Palermo
OTHER
Responsible Party
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Antonino Tuttolomondo
University professor
Principal Investigators
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Antonino Tuttolomondo, Professor
Role: STUDY_DIRECTOR
University of Palermo
Locations
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Internal Medicine Ward, University of Palermo
Palermo, , Italy
Countries
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Other Identifiers
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U Palermo
Identifier Type: -
Identifier Source: org_study_id