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Sympathetic Transduction in Obesity-associated Hypertension (OB-HTN)
Plain-language guide to NCT04838678: early phase 1 non-randomized trial of Neuropeptide Y, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04838678
- Phase
- early phase 1
- Status
- recruiting participants
- Start
- 2021-07-18
- Completion (planned or actual)
- 2026-12-31
- Participants
- 100 (estimated)
- Design
- non-randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Hypertension; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (early phase 1) is built around Neuropeptide Y.
The study will also investigate how hypertension and obesity influence the nervous system and vascular function.
The study will involve measuring sympathetic nervous system activity and blood flow during common laboratory physiological stress protocols (e.g. hypoxia, exercise), and in response to infusion of drugs that cause vasodilation or vasoconstriction.
It had four arms (groups): Healthy Control (experimental), Hypertensive (experimental), Obese (experimental) and Obese-hypertensive (experimental).
Healthy age matched controls with no history of cardiovascular disease and normal bodyweight.
Hypertensive adults who are not obese.
Obese adults who are not hypertensive.
The registry classes the interventions as drug.
Who Took Part
The registry lists 100 planned participants were the target.
It was open to people of any sex aged from 18 years up to 55 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Control - BMI\<30, age 18-55.
The full record lists 2 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was non-randomized, parallel-group and open-label.
The Neuropeptide Y group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Neuropeptide Y study: the participants and staff both knew the treatment.
It started in 2021-07-18 with completion listed for 2026-12-31.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Blood flow measured by doppler ultrasound (time frame: Acutely on the day of study). Muscle sympathetic nervous system activity (time frame: Acutely on the day of study).
What This Means in Plain Language
Put simply, this is a early phase 1, non-randomized trial of Neuropeptide Y in 100 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Neuropeptide Y compound page, all human trials.
Our Notes on the Compound
Neuropeptide Y: A 36-amino-acid brain and nerve peptide involved in appetite, stress and blood-vessel tone; studied as an intranasal spray.
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.