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

NCT03444142 | Unknown Phase 4

• 1 other identifier: Exenatida LAR Dulaglutida-with
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Hyperglycemia; ABPM; Variability of blood pressure; Exenatide LAR or Dulaglutide 0.75mg; Glucagon-like peptide analogues type 1 (GLP1).

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (16)

• Categories: dipper o non dipper

  Baseline to Week 4

• Fasting glucose levels

  Baseline to Week 4

• Central and peripheral blood pressure

  Baseline to Week 4

• Pulse wave velocity

  Baseline to Week 4

• Cardio-ankle Vascular Index (CAVI)

  Baseline to Week 4

Study Arms (2)

Drug: Exenatide LAR

ACTIVE COMPARATOR

Exenatide LAR 2 mg, once weekly subcutaneously before breakfast during 4 weeks.

Drug: Exenatide LAR

Drug: Dulaglutide

ACTIVE COMPARATOR

Dulaglutide .75 mg, once weekly subcutaneously Before breakfast during 4 weeks.

Drug: Dulaglutide

Interventions

Exenatide LAR DRUG

2 mg, once weekly subcutaneously before breakfast during 4 weeks.

Also known as: Bydureon

Drug: Exenatide LAR

Dulaglutide DRUG

.75 mg once weekly subcutaneously before breakfast during 4 weeks.

Also known as: Trulicity

Drug: Dulaglutide

Eligibility Criteria

• Age: 31 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Instituto de terapeutica Experimental y Clinica. Centro universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hyperglycemia

Interventions

Exenatide; dulaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• MANUEL GONZALEZ, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MANUEL GONZALEZ, PhD

CONTACT

+523310585200; uiec@prodigy.net.mx

KARINA PEREZ, PhD

CONTACT

+523310585200; karina2410@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 23, 2018
• Study Start: November 17, 2017
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

ME (1)