Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-29 @ 7:27 PM
Study NCT ID:
NCT01938469
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2013-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery
Sponsor:
St. Luke's-Roosevelt Hospital Center
Organization:
Study Overview
Official Title:
Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery
Status:
COMPLETED
Status Verified Date:
2016-12
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:
Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric bypass surgery (GBP).
Detailed Description:
The main goal is to study the effect of meal number, size and texture on metabolism and incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small isocaloric meals, with the order of the conditions randomly assigned. The total amount of calories and the overall nutrient composition will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals.
Gastric emptying will be measured by the acetaminophen test.
Gastric emptying will be measured by the acetaminophen test.
Study Oversight
Has Oversight DMC:
False
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?: