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

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ClinicalTrials.gov Identifier: NCT03444142
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Manuel González Ortiz, University of Guadalajara

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Exenatide LAR Drug: Dulaglutide Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : November 17, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Drug: Exenatide LAR
Exenatide LAR 2 mg, once weekly subcutaneously before breakfast during 4 weeks.
Drug: Exenatide LAR
2 mg, once weekly subcutaneously before breakfast during 4 weeks.
Other Name: Bydureon

Active Comparator: Drug: Dulaglutide
Dulaglutide .75 mg, once weekly subcutaneously Before breakfast during 4 weeks.
Drug: Dulaglutide
.75 mg once weekly subcutaneously before breakfast during 4 weeks.
Other Name: Trulicity




Primary Outcome Measures :
  1. Heart rate: nighttime, daytime and 24-h [ Time Frame: Baseline to Week 4 ]
    heart rate variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O3

  2. Systolic blood pressure, daytime, night and 24 h [ Time Frame: Baseline to Week 4 ]
    Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O33.

  3. Diastolic blood pressure, daytime, night and 24 h [ Time Frame: Baseline to Week 4 ]
    Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O3

  4. Blood pressure [ Time Frame: Baseline to Week 4 ]
    Blood pressure will be measured at baseline and week 4 with a digital sphygmomanometer and the entered values reflect the blood pressure.


Secondary Outcome Measures :
  1. Categories: dipper o non dipper [ Time Frame: Baseline to Week 4 ]
    Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hrs by oscillometric method Microlife WatchBP O3

  2. Fasting glucose levels [ Time Frame: Baseline to Week 4 ]
    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

  3. Central and peripheral blood pressure [ Time Frame: Baseline to Week 4 ]
    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.

  4. Pulse wave velocity [ Time Frame: Baseline to Week 4 ]
    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.

  5. Cardio-ankle Vascular Index (CAVI) [ Time Frame: Baseline to Week 4 ]
    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.

  6. Glycosylated hemoglobin [ Time Frame: Baseline to Week 4 ]
    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

  7. Body Weight [ Time Frame: Baseline to Week 4 ]
    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

  8. Body Mass Index [ Time Frame: Baseline to Week 4 ]
    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

  9. Total cholesterol [ Time Frame: Baseline to Week 4 ]
    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

  10. Triglycerides levels [ Time Frame: Baseline to Week 4 ]
    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

  11. High density lipoprotein (c-HDL) levels [ Time Frame: Baseline to Week 4 ]
    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

  12. Alanine aminotransferase (ALT) levels [ Time Frame: Baseline to Week 4 ]
    ALT levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques

  13. Aspartate aminotransferase (AST) levels [ Time Frame: Baseline to Week 4 ]
    AST levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques [Time Frame: Baseline to Week 4

  14. Creatinine levels [ Time Frame: Baseline to Week 4 ]
    Creatinine levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques

  15. Uric acid levels [ Time Frame: Baseline to Week 4 ]
    Uric acid levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques

  16. Waist Circumference [ Time Frame: Baseline, week 4 ]
    Waist circumference will be evaluated at baseline and at week 4 with a flexible tape



Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444142


Contacts
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Contact: MANUEL GONZALEZ, PhD +523310585200 ext 34212 uiec@prodigy.net.mx
Contact: KARINA PEREZ, PhD +523310585200 ext 34212 karina2410@hotmail.com

Locations
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Mexico
Instituto de terapeutica Experimental y Clinica. Centro universitario de Ciencias de la Salud. Universidad de Guadalajara Recruiting
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
University of Guadalajara
Investigators
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Principal Investigator: MANUEL GONZALEZ, PhD University of Guadalajara

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Responsible Party: Manuel González Ortiz, PhD, University of Guadalajara
ClinicalTrials.gov Identifier: NCT03444142     History of Changes
Other Study ID Numbers: Exenatida LAR Dulaglutida-with
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manuel González Ortiz, University of Guadalajara:
Diabetes
Hyperglycemia
ABPM
Variability of blood pressure
Exenatide LAR or Dulaglutide 0.75mg
Glucagon-like peptide analogues type 1 (GLP1).

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Dulaglutide
Immunoglobulin Fc Fragments
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors