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Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin
Plain-language guide to NCT04055025: not phased interventional trial of Ghrelin, 12 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04055025
- Phase
- not phased
- Status
- completed
- Start
- 2020-02-28
- Completion (planned or actual)
- 2022-05-12
- Participants
- 12 (actual)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Bariatric Surgery
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Ghrelin.
It had 1 arm (groups): Sleeve gastrectomy operated patients (other).
Six test days in a randomized, patient-blinded, cross-over design.
The registry classes the interventions as other.
More on the Plan
Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are to bariatric procedure.
After both procedures, a changed secretion of hormones from the gastrointestinal tract is believed to affect appetite and glucose metabolism.
Ghrelin stimulates food intake through appetite-regulating centers in the hypothalamus.
Administration of exogenous ghrelin has been reported to stimulate appetite.
Who Took Part
Enrollment: 12 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: The Danish national inclusion criteria for bariatric surgery. Signed written informed consent.
The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: pregnancy or breastfeeding; hemoglobin \<6.5 mm; newly emerged serious disease.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Ghrelin study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2020-02-28 with completion listed for 2022-05-12.
It ran at 1 site in Denmark.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: Ad libitum (time frame: 240 minutes).
It also tracked 2 secondary outcomes, for example Ad libitum and Ghrelin.
What This Means in Plain Language
Put simply, this is a not phased trial of Ghrelin in 12 people.
Its size is small, so on its own it can only give an early look.
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.