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

What Was Tested

The trial (phase 4) is built around Exenatide and Dulaglutide for low blood pressure and orthostatic hypotension.

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.

It had two arms (groups): Drug: Exenatide LAR (active comparator) and Drug: Dulaglutide (active comparator).

The registry classes the interventions as drug.

More on the Plan

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

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.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 31 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients both sexes. Age between 31 and 60 years. Diagnosis of diabetes according ADA criteria:.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: women with confirmed or suspected pregnancy; women under lactation and/or puerperium; hypersensibility to ingredients of intervention.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The low blood pressure and orthostatic hypotension participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the low blood pressure and orthostatic hypotension participants stayed in one arm throughout.

Nothing was hidden in this open-label Exenatide study: the low blood pressure and orthostatic hypotension participants and staff both knew the treatment.

It started in 2017-11-17 with completion listed for 2021-11-30.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Heart rate: nighttime, daytime and 24-h (time frame: Baseline to Week 4). Systolic blood pressure, daytime, night and 24 h (time frame: Baseline to Week 4). Diastolic blood pressure, daytime, night and 24 h (time frame: Baseline to Week 4).

It also tracked 16 secondary outcomes, for example Categories: dipper o non dipper, Fasting glucose levels, Central and peripheral blood pressure, Pulse wave velocity, Cardio-ankle Vascular Index (CAVI) and Glycosylated hemoglobin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Dulaglutide in 30 people with low blood pressure and orthostatic hypotension.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page and the Dulaglutide compound page, Low blood pressure and orthostatic hypotension research.