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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT03444142 (opens ClinicalTrials.gov in a new tab)Other idExenatida LAR Dulaglutida-with
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Overview

Status
Status unknown
Phase
Phase 4
Enrollment
30 participants (estimated)
Sponsor
University of Guadalajara · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Mexico

Start
17 Nov 2017
Primary completion
30 Nov 2021 (estimated)
Completion
30 Nov 2021 (estimated)
First posted
23 Feb 2018
Last update posted
26 Mar 2020
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019202020212022
  1. Ph 4

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

    NCT03444142

    17 Nov 2017 to est. 30 Nov 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Exenatide LARDrug
  • DulaglutideDrug

Arms2

  • Active comparator

    Drug: Exenatide LAR

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

  • Active comparator

    Drug: Dulaglutide

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

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Heart rate: nighttime, daytime and 24-h

    Time frame · Baseline to Week 4

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Blood pressure will be measured at baseline and week 4 with a digital sphygmomanometer and the entered values reflect the blood pressure.

Secondary outcomes(16)

  1. Categories: dipper o non dipper

    Time frame · Baseline to Week 4

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Creatinine levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques

  15. Uric acid levels

    Time frame · Baseline to Week 4

    Registry description

    Uric acid levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques

  16. Waist Circumference

    Time frame · Baseline, week 4

    Registry description

    Waist circumference will be evaluated at baseline and at week 4 with a flexible tape

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 31 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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