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Preprandial Ghrelin Effect
Plain-language guide to NCT02913703: phase 1 non-randomized trial of Ghrelin, 80 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02913703
- Phase
- phase 1
- Status
- completed
- Start
- 2017-01-11
- Completion (planned or actual)
- 2018-12
- Participants
- 80 (estimated)
- Design
- non-randomized, single-blind, basic_science
- Conditions studied
- Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Ghrelin.
Released mainly by the stomach and proximal small intestine, ghrelin peaks prior to meals, potentially priming the gut for anticipated nutrients.
After eating, ghrelin abruptly declines, with levels varying 2- to 3-fold between the fasted and fed states.
It had six arms (groups): one (experimental), Healthy subjects - Preprandial saline (experimental), one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug and other.
Who Took Part
The registry lists 80 planned participants were the target.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: BMI 25.0 - 45.0 kg/m2. BMI 18.0 - 29.9 kg/m2. Age between 18 - 40 years.
The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: active infections; history of malignant or inflammatory conditions, such as rheumatoid arthritis and inflammatory bowel disease; history of myocardial infarction or congestive heart failure.
How the Study Was Run
Design: non-randomized, parallel-group and single-blind.
The Ghrelin group and the comparison group ran side by side rather than switching.
In this single-blind Ghrelin study one party knew the assignments and the other did not.
Those kept unaware of assignments: participant.
It started in 2017-01-11 with completion listed for 2018-12.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Effect of preprandial ghrelin on glucose tolerance (time frame: Approximately 4-8 weeks).
It also tracked 4 secondary outcomes, for example Effect of preprandial ghrelin on GLP-1 secretion, Effect of preprandial ghrelin on insulin secretion, Effect of preprandial ghrelin on beta cell function and Effect of preprandial ghrelin on insulin sensitivity (as measured by Matsuda index).
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Ghrelin in 80 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Ghrelin compound page, all human trials.
Our Notes on the Compound
Ghrelin: A 28-amino-acid stomach hormone that signals hunger and triggers growth hormone release; studied in human trials as an infusion.
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.