Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT00965302
Status:
TERMINATED
Last Update Posted:
2023-04-25
First Post:
2009-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleeve Gastrectomy Versus Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients
Sponsor:
59th Medical Wing
Organization:
Study Overview
Official Title:
Sleeve Gastrectomy vs Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator did not submit an annual continuation report with the Institutional Review Board and the study was officially removed from IRB regulatory oversight on Sep 2014, based on 32 CFR 219.109e. The study officially expired/terminated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with medical management, with a primary endpoint of diabetes remission (normal fasting glucose, off medications and insulin) at one year. Sleeve gastrectomy (also called greater curvature gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection of the gastric fundus. Secondary endpoints include weight loss, improvement in hypertension, sleep apnea, c-reactive protein, and fasting lipid profile.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: