A Phase 2 interventional study of Omentectomy and No intervention in Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2, Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy and Age 18-64 Years, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-11-20.
Sponsored by NYU Langone Health · Phase 2, Interventional, and Treatment
PROTOCOL SUMMARY
Type of Study: Pilot, randomized and single center trial Test Procedure: Omentectomy Aim 1. Determine the effect of omentectomy on 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation We hypothesize that removal of omental fat increases insulin sensitivity and pancreatic sensitivity to glucose, and decreases systemic inflammation.
Aim 2. Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study.
We hypothesize that the genetic samples will help us to identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity and help us to design future obesity genetic studies.
Total Enrollment Number: 30 patients who are scheduled to undergo bariatric surgery for weight loss at New York University Medical Center will be invited to participate in this study. Subjects will be randomly assigned, by using a computer-generated randomization scheme, in a single-blind fashion to either the omentectomy (n=15) or control group (n=15).
Inclusion Criteria:
Exclusion Criteria:
Research Design- Pilot Study Event Week (approximate) Medical Screening (in conjunction with routine pre-op visit) -4 OGTT \& randomization -2 Preliminary genetic testing for the future study (blood sample) -2 Surgery with or without omentectomy 0 Preliminary genetic testing for the future study (fat sample) 0 Weight stabilization visit (in conjunction with routine post-op visit) 2 Weight stabilization visit (in conjunction with routine post-op visit) 4 OGTT 6
STUDY PLAN
Study has approved by IRB, NYU School of Medicine Committee, GCRC, and Bellevue Hospital.
Study initiation date: November 01, 2007
Enrollment period: Nov. 2007 to Nov. 2008
Study period: Nov. 2007 to Jan 2008
9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 11 is below the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →NYU Langone Health is the lead sponsor of 1,390 studies on the registry; 253 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LAGB \& Omentectomy
Procedure: Omentectomy
LAGB Only
Other: No intervention
Removing the omentum
Only LAGB without Omentectomy
1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation
Time frame: 6 week post op
Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study.
Time frame: 6 week post op
This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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NYU Langone Health