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Ghrelin and Insulin Resistance
Plain-language guide to NCT00884494: phase 1 randomized trial of Ghrelin, insulin resistance, prediabetes & type 2 diabetes, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00884494
- Phase
- phase 1
- Status
- completed
- Start
- 2011-08
- Completion (planned or actual)
- 2014-05
- Participants
- 20 (actual)
- Design
- randomized, single-blind, basic_science
- Conditions studied
- Obesity; Insulin Resistance; Normal Weight,Healthy Controls
- 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 for insulin resistance, prediabetes & type 2 diabetes.
Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines immediately after weight loss surgery.
It had two arms (groups): Roux-en-Y gastric bypass (experimental) and Lean (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 20 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: BMI \> 35 kg/m2. BMI \< 30kg/m2.
The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: prior bariatric surgery; hepatic enzyme elevations \> 2x upper limits of normal; current use of warfarin or clopidogrel.
How the Study Was Run
It was run as a randomized, crossover and single-blind study.
Random assignment meant chance, not the researchers, decided who got Ghrelin and who got the comparison, which limits bias.
In the crossover set-up each of the insulin resistance, prediabetes & type 2 diabetes participants took both Ghrelin and the comparison in turn, acting as their own control.
Only one side, usually the insulin resistance, prediabetes & type 2 diabetes participants, was kept unaware of whether Ghrelin was given.
Those kept unaware of assignments: participant.
It started in 2011-08 with completion listed for 2014-05.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: Evaluate the effect of ghrelin on insulin resistance in obese subject, as well as subjects in the immediate post-RYGB period (time frame: 1 year).
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Ghrelin in 20 people with insulin resistance, prediabetes & type 2 diabetes.
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, Insulin resistance, prediabetes & type 2 diabetes research.
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.