Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 12:04 AM
Study NCT ID:
NCT03238794
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-05
First Post:
2017-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Effect of Weight Loss Through RYGB Versus Weight Loss Through Caloric Restriction on the Bile Acid Pathway
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
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:
It is unknown whether the bile acid pathway reacts differently to weight loss resulting from Roux-En-Y Gastric Bypass (RYGB) surgery than weight loss resulting from caloric restriction alone.
Detailed Description:
Participants will be placed into two groups. The Roux-En-Y Gastric Bypass (RYGB) group will consist of participants who will have elected to have RYGB at the Mayo Clinic Bariatric Center of Excellence. The Diet group will have a low-calorie diet prescribed by a registered dietitian. Both groups will collect stool from every bowel movement 2 days before presenting for baseline testing. Both group participants will present for baseline testing after an overnight fast and before intervention (RYGB or low calorie diet). Participants will consume a standard breakfast provided by study staff and blood samples will be collected at -15, 0, 15, 30,45,60,90,120,150,180,210,240,300,360 minutes. Appetite and satiation ratings will be recorded via questionnaires during that day every 15 minutes for the first 90 minutes, then every 30 minutes. Participants will repeat this regimen again after losing 7% of their body weight after having RYGB or low calorie diet.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23DK114460 | NIH | None | https://reporter.nih.gov/quic… | View |