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Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)

Plain-language guide to NCT03883412: phase 4 randomized trial of Liraglutide, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03883412
Phase
phase 4
Status
recruiting participants
Start
2019-02-28
Completion (planned or actual)
2027-06
Participants
60 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Type2 Diabetes
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Liraglutide.

Subjects will be randomized to one of the three groups: exercise training, liraglutide treatment, and exercise + liraglutide.

It had three arms (groups): Exercise Alone (experimental), Liraglutide alone (experimental) and Exercise + Liraglutide (experimental).

16 weeks of treatment.

16 weeks of treatment.

16 weeks of treatment.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 21 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Never on GLP-1RA (eg: exenatide, liraglutide) or DPP4I ( eg: Sitaglipton).

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: taking insulin; smoking presently or in the past 6 months; BP \>160/90.

How the Study Was Run

It was run as a randomized, factorial and open-label study.

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

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-02-28 with completion listed for 2027-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Microvascular Blood Volume - change from baseline (time frame: 16 weeks).

It also tracked 5 secondary outcomes, for example Augmentation Index - change from baseline, Flow Mediated Dilation - change from baseline, Pulse Wave Velocity - change from baseline, Post Ischemic Flow Velocity-Change from baseline and Insulin Sensitivity-Change from baseline.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

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.