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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of the Weekly Administration of Exenatide LAR or Dulaglutide on the Variability of Blood Pressure and Heart Rate of 24 Hours in Patients With Type 2 Diabetes Mellitus Without Pharmacological Treatment.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03444142
• Other study ID #: Exenatida LAR Dulaglutida-with
• Status: Recruiting
• Phase: Phase 4
• Start date: November 17, 2017
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2020
• Source: University of Guadalajara
• Contact: MANUEL GONZALEZ, PhD
• Phone: +523310585200
• Email: uiec[@]prodigy.net.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A randomized, open clinical trial of 30 patients with a diagnosis of diabetes in accordance with the American Diabetes Association (ADA) without treatment.

They will be assigned randomly in two groups of 15 patients each to receive 2 mg subcutaneous of Exenatide LAR (Bydureon by Astra Zeneca) or Dulaglutide .75 mg (trulicity, by Lilly), once weekly before breakfast during 4 weeks.

There will be calculated body mass index (BMI); low-density lipoprotein cholesterol (LDL-c); very-low density lipoprotein (VLDL), glomerular filtration rate and blood pressure variability. This protocol it's already approved by the local ethics committee with number CEI/447/2017 and written informed consent it's going to be obtained from all volunteers.

Statistical analysis will be presented through measures of central tendency, dispersion, average and deviation standard for quantitative variables, frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Exenatide LAR
2 mg, once weekly subcutaneously before breakfast during 4 weeks.
• Dulaglutide
.75 mg once weekly subcutaneously before breakfast during 4 weeks.

Locations

Country	Name	City	State
Mexico	Instituto de terapeutica Experimental y Clinica. Centro universitario de Ciencias de la Salud. Universidad de Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate: nighttime, daytime and 24-h	heart rate variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O3	Baseline to Week 4
Primary	Systolic blood pressure, daytime, night and 24 h	Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O33.	Baseline to Week 4
Primary	Diastolic blood pressure, daytime, night and 24 h	Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O3	Baseline to Week 4
Primary	Blood pressure	Blood pressure will be measured at baseline and week 4 with a digital sphygmomanometer and the entered values reflect the blood pressure.	Baseline to Week 4
Secondary	Categories: dipper o non dipper	Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hrs by oscillometric method Microlife WatchBP O3	Baseline to Week 4
Secondary	Fasting glucose levels	The fasting glucose levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 4	Baseline to Week 4
Secondary	Central and peripheral blood pressure	To determine and compare the effect of administration of Exenatide LAR or Dulaglutide on Central and peripheral blood pressure through HEM will be evaluated at baseline and week 4.	Baseline to Week 4
Secondary	Pulse wave velocity	To determine and compare the effect of administration of Exenatide LAR or Dulaglutide on pulse wave velocity through VP1000-plus with Ankle-Brachial Index will be evaluated at baseline and week 4.	Baseline to Week 4
Secondary	Cardio-ankle Vascular Index (CAVI)	To determine and compare the effect of administration of Exenatide LAR or Dulaglutide on arterial stiffness through Cardio-ankle Vascular Index (CAVI) will be evaluated at baseline and week 4.	Baseline to Week 4
Secondary	Glycosylated hemoglobin	Glycosylated hemoglobin will be evaluated at baseline and week 4 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 4	Baseline to Week 4
Secondary	Body Weight	The body weight will be measured at baseline and week 4 with a bioimpedance balance and the entered values reflect the body weight at week 4	Baseline to Week 4
Secondary	Body Mass Index	Body Mass Index will be calculated at baseline and week 4 with the Quetelet index formula and the entered values reflect the body mass index at week 4	Baseline to Week 4
Secondary	Total cholesterol	Total cholesterol levels will be evaluated at baseline and week 4 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 4	Baseline to Week 4
Secondary	Triglycerides levels	Triglycerides levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 4	Baseline to Week 4
Secondary	High density lipoprotein (c-HDL) levels	c-HDL levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 4	Baseline to Week 4
Secondary	Alanine aminotransferase (ALT) levels	ALT levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques	Baseline to Week 4
Secondary	Aspartate aminotransferase (AST) levels	AST levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques [Time Frame: Baseline to Week 4	Baseline to Week 4
Secondary	Creatinine levels	Creatinine levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques	Baseline to Week 4
Secondary	Uric acid levels	Uric acid levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques	Baseline to Week 4
Secondary	Waist Circumference	Waist circumference will be evaluated at baseline and at week 4 with a flexible tape	Baseline, week 4