Effect of Exenatide LAR or Dulaglutide on the Variability of 24-hour Heart Rate and Blood Pressure in Type 2 Diabetes

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Mortality due to cardiovascular problems is increased by having Diabetes Mellitus type 2 (DM2), related to the time of evolution and glucose levels or if alterations in blood pressure coexist. With this variability there is greater damage to the target organ and in patients with DM2 the process is more severe and frequent due to alterations in the coagulation mechanisms that accelerate in the presence of hypertension, figures ≥135 / 85 mmHg are considered risk factors to develop coronary, cerebral or renal events. As a quantitative range, blood pressure is currently monitored ambulatory by (MAP) which is the most used and reliable non-invasive instrument for its evaluation. The American Association of Clinical Endocrinologists (AACE) proposes an algorithm that contemplates initiating management to patients with a diagnosis of diabetes with drugs such as metformin, thiazolidinediones and glucagon-like peptide analogues type 1 (GLP1).

Exenatide LAR and Dulaglutide are GLP-1 analogue drugs with potential to decrease the progressive losses of pancreatic β cell function and mass and cardiovascular risk (CV) factors with maintained use, in addition to hypoglycemic, hypotensive effects, weight decreases and visceral adiposity, however, it has been reported that although they share the same basic mechanism of action, each one has a different molecular structure and pharmacokinetic profile that make their pharmacological and clinical effects different, in particular as regards the variability of blood pressure and heart rate.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Dulaglutide; Exenatide; Immunoglobulin Fc Fragments

Criteria

Inclusion Criteria:

• Patients both sexes

• Age between 31 and 60 years

• Diagnosis of diabetes according ADA criteria:

(Fasting blood glucose levels >125 mg/dl or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose > 200 mg/dl, or glycosylated hemoglobin >6.5%).

• Informed consent signed

Exclusion Criteria:

• Women with confirmed or suspected pregnancy

• Women under lactation and/or puerperium

• Hypersensibility to ingredients of intervention

• Physical impossibility for apply the drug

• Known pancreatic, renal, hepatic, heart or thyroid diseased

• Hypertension diagnosis

• Previous treatment for glucose

• Body Mass Index ≥39.9 kg/m2

• Triglycerides ≥500 mg/dL

• Total cholesterol ≥300 mg/dL

• Night or rotating shift workers

• Blood Pressure ≥140/90 mmHg