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Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function
Plain-language guide to NCT02584075: phase 4 interventional trial of Exenatide, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02584075
- Phase
- phase 4
- Status
- status unknown
- Start
- 2015-11
- Completion (planned or actual)
- 2017-11
- Participants
- 100 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Coronary Endothelial Function
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Exenatide.
Type 2 diabetes mellitus (T2DM) is an important risk factor of cardio-cerebral vascular disease such as coronary heart disease.
GLP-1 is a kind of incretin secreted by the L-cell located in Ileum.
It acts as an incretin hormone by protentiating glucose-stimulated insulin release.
It had 1 arm (groups): Lifestyle intervention (experimental).
The registry classes the interventions as drug.
Who Took Part
100 planned participants were the target.
It was open to people of any sex aged from 20 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Females or males, and aged 20 to 65 years. Newly diagnose type 2 diabetes mellitus with BMI\>25kg/m2.
The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: type 1 diabetes mellitus, diabetic ketoacidosis, diabetic hyperosmolar coma; hepatic insufficiency (alt or ast\> 1.5\*uln); thyroid disease.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2015-11 with completion listed for 2017-11.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Coronary endothelial function (time frame: the change of coronary endothelial function(baseline, 12 weeks)).
It also tracked 6 secondary outcomes, for example the changes of fasting plasma glucose (FPG), the changes of HbA1C, the changes of fasting serum insulin (FINS), the changes of IL-1B, the changes of IL-6 and the changes of TNF-α.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Exenatide in 100 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Exenatide compound page, all human trials.
Our Notes on the Compound
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.