Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes

What Was Tested

In this not phased trial, researchers set out to test Exenatide.

Of great concern, the majority of people with type 2 diabetes are sedentary and one possible reason may be that exercise, even at low levels, is perceived as being a harder effort than for nondiabetic people.

It had two arms (groups): Exenatide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Subjects will come for a total of seven testing visits, including two screening visits, during which evaluations will take place.

Visits are structured as follows: Visits 1, 2 and 3 will be completed over a four-week period. 1.

After subjects review the study and give consent for study participation, a history and physical exam will be performed.

In addition, the Low-level Physical Activity Recall (LoPAR) questionnaire, pulmonary function testing, and vital signs will be performed. 2.

Who Took Part

Enrollment: 23 actual participants took part.

It was open to people of any sex aged from 45 years up to 70 years.

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

Examples of who could join: Men and women between the ages of 45 and 70 years of age. Diagnosed with uncomplicated type 2 diabetes. Sedentary persons (exercising not more than one time per week). Females who are post-menopausal. BMI must be less than 35.

The full record lists 10 inclusion and 15 exclusion criteria; among the exclusions: people with type 2 diabetes (t2d) taking oral medications, other than metformin or sulfonylurea drugs or meglitinides, to control their diabetes; persons treated with insulin will be excluded; people who are currently smoking or have not quit for at least one year.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant and investigator.

It started in 2010-10 with completion listed for 2014-12.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Peak Oxygen Consumption (VO2 Peak) (time frame: Baseline and 3 months).

It also tracked 14 secondary outcomes, for example Oxygen Uptake Kinetics Steady State Tau, Change From Baseline in Arterial Stiffness, Change From Baseline in Peak Dilation of Brachial Artery Diameter, Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise, Echocardiographic Measures - Circumferential Strain and Echocardiographic Measures - Longitudinal Strain.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 23 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.