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, Age 18-64 Years
Conditions
Keywords
DM
Brief summary
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).
Detailed description
Inclusion Criteria: * Patients who consented to undergo LAGB for weight loss and consent to participate in this study * BMI ≥35 kg/m2 * Confirmed T2DM treated with oral agents and/or only diet therapy * Age 18-64 years Exclusion Criteria: * Insulin therapy * Weight change (\>2% body weight) within 4 weeks before surgery * Patients with T2DM for more than 10 years 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
Interventions
PROCEDUREOmentectomy
Removing the omentum
OTHERNo intervention
Only LAGB without Omentectomy
Sponsors
Washington University School of Medicine
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Patients who consented to undergo LAGB for weight loss and consent to participate in this study * BMI ≥35 kg/m2 * Confirmed T2DM treated with oral agents and/or only diet therapy * Age 18-64 years
Exclusion criteria
* Insulin therapy * Weight change (\>2% body weight) within 4 weeks before surgery * Patients with T2DM for more than 10 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation | 6 week post op |
Secondary
| Measure | Time frame |
|---|---|
| Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study. | 6 week post op |
Countries
United States
Outcome results
None listed