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RYGB and the Gastric Adipose Axis
Plain-language guide to NCT01474785: phase 1 non-randomized trial of Ghrelin, 49 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01474785
- Phase
- phase 1
- Status
- completed
- Start
- 2012-01
- Completion (planned or actual)
- 2015-07
- Participants
- 49 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Obesity
- 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.
It had three arms (groups): RYGB (experimental), VSG (experimental) and Low Calorie Diet (experimental).
Roux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively.
Vertical sleeve gastrectomy (VSG) subjects to undergo hyperinsulinemic-euglycemic clamp pre-operatively and post-operatively.
Subjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet.
The registry classes the interventions as drug, other and procedure.
Who Took Part
The registry lists 49 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 18-65 years. BMI ≥ 35 kg/m\^2. Scheduled for bariatric surgery. Considering bariatric surgery. Waiting for insurance approval for bariatric surgery.
The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: smoking \>7 cigarettes per day; precious malabsorptive or restrictive intestinal surgery; pregnant or breastfeeding.
How the Study Was Run
The set-up was non-randomized, parallel-group and open-label.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Ghrelin study: the participants and staff both knew the treatment.
It started in 2012-01 with completion listed for 2015-07.
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: change in glucose disposal rate (time frame: baseline and 1 week).
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Ghrelin in 49 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.