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The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy
Plain-language guide to NCT06461377: phase 4 randomized trial of Semaglutide, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06461377
- Phase
- phase 4
- Status
- recruiting participants
- Start
- 2024-06-13
- Completion (planned or actual)
- 2026-12-31
- Participants
- 50 (estimated)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Type 2 Diabetes; Diabetes With Diabetic Autonomic Neuropathy (Diagnosis)
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Semaglutide.
The onset of DCAN is insidious and easy to be ignored in the early stage.
It had two arms (groups): control (no intervention) and GLP-1RA intervention group (experimental).
In the control group, no other intervention was used except the basic drugs for diabetes treatment.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 50 planned participants were the target.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients aged 18-70 years. Patients with T2DM who meet the diagnostic guidelines. The patient signed the relevant informed consent form. Being overweight or obese.
The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: \<18 years old; pregnant or lactating women; acute and chronic pancreatitis.
How the Study Was Run
The set-up was randomized, parallel-group and single-blind.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
The Semaglutide group and the comparison group ran side by side rather than switching.
Only one side, usually the participants, was kept unaware of whether Semaglutide was given.
Those kept unaware of assignments: outcomes assessor.
It started in 2024-06-13 with completion listed for 2026-12-31.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): heart rate variability（HRV） (time frame: baseline and 12 weeks later).
It also tracked 19 secondary outcomes, for example E/I difference, 30/15 ratio, Valsalva action, the difference between lying and Orthostatic blood pressure, grip strength tests and BMI.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Semaglutide in 50 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
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.