Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108225
Status:
COMPLETED
Last Update Posted:
2014-07-01
First Post:
2005-04-14
Brief Title:
Effect of a High Protein Diet on the 24-hour Profile of Ghrelin GH Growth Hormone and IGF-1 Insulin-like Growth Factor-1
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
2895 Effect of a High Protein Diet on the 24-hr Profile of Ghrelin GH and IGF-1
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study we tested the hypothesis that an increase in protein content of the diet will result in an increase in the 24-hour integrated circulating growth hormone GH and insulin-like growth factor-1 IGF-1 concentrations and an increase in lean body mass in people with untreated type 2 diabetes
Detailed Description:
Subjects with untreated type 2 diabetes were studied using a randomized crossover design The study began with an initial two-week observation period Subjects then were randomly assigned to one arm of the study for 5 weeks The carbohydrateproteinfat ratio for the control diet is 551530 whereas for the test diet it is 403030 Following a five-week washout period subjects were assigned to the other arm of the study All meals were provided by the SDTU A six-day rotating meal plan has been devised At the beginning and end of the 5-week diet period the subject was admitted to the SDTU Special Diagnostic and Treatment Unit was provided with the meals appropriate for the test or control arm of the study and had blood drawn at various times during a 24-hour period In addition to measurement of GH and IGF-1 IGF-binding proteins 1 and 3 ghrelin and body composition were determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None