Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547515
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Bone and Muscle Health Following Sleeve Gastrectomy in Men Premenopausal and Postmenopausal Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bone and Muscle Health Following Sleeve Gastrectomy in Men Premenopausal and Postmenopausal Women
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BONUS
Brief Summary:
Background Bariatric surgery is gaining in popularity While its health benefits are undisputed the older malabsorptive bariatric procedures Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD are associated with an increased risk of fractures and falls as early as 3-5 years after surgery Sleeve gastrectomy - SG is now the most performed bariatric procedure Although SG does not cause malabsorption it is predicted to result in bone and muscle loss via weight loss and weight loss-independent mechanisms Primary aim to compare the changes in spine volumetric bone mineral density vBMD by quantitative computed tomography QCT and muscle mass at mid-femur by computed tomography CT at 3 years in the 3 groups of 1 men 2 premenopausal women 3 postmenopausal women after SG versus their respective non-surgical peers who did not undergo SG in the 3-year period following recruitment Secondary aims to compare the changes in vBMD by QCT at skeletal sites other than the spine and in areal bone mineral density aBMD by dual-energy X-ray absorptiometry DXA whole-body muscle mass by DXA muscle quality by CT at mid-femur and muscle strength as well as in selected physical performance and capacity tests shown to predict falls and fractures between 0-1 and 1-3 years after SG in the same 3 groups after SG vs in the respective non-surgical groups
Detailed Description:
None
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