Research is a very important component of the comprehensive care we offer to our patients. Participating in research offers you the opportunity to help us learn more about obesity and improve treatment. Every patient who comes for a weight loss surgery consultation at the Weill Cornell Weight Loss Surgery Program will be invited to join our ongoing clinical trials. The Institutional Review Board of Weill Cornell Medical College has approved all of the clinical trials listed.

1. NIDDK LABS Center (DK 03-006)

• PI: Paul Berk

LABS 1, Longitudinal Assessment of Bariatric Surgery. #0411007552 LABS2 0508008060

• PI (Weill Cornell) : Alfons Pomp, MD
• Investigators: Drs. Strain, Dakin, Ebel, and Young

An evaluation of 30 day mortality after bariatric procedures will be completed in 1200 patients. Comprehensive longer term assessment, 2,400 patients in LABS2. This protocol will assess the long-term effects of weight loss on health, gender issues, behavioral factors, work and leisure activities over 3 years. For more information on the LABS Consortium and their ongoing research go to: www.niddklabs.org

2. A Gene Expression And Metabolic Profile of Weight Loss: Studies of Patients Following Gastric Bypass Surgery Friedman. (# JFN-0385-0404; Rockefeller University, Weill Cornell #0604-343)

• PI: Alfons Pomp, MD
• Investigators: Drs. Dakin and Strain, NIH supported; a subcontract for Rockefeller for recruitment.

This is a longitudinal study of obese patients prior to gastric bypass surgery and interval follow-up of changes in gene expression and metabolic changes from resultant weight loss over 18 months. Weill Cornell screens and refers patients. Weill Cornell does not consent. Total 10 patients who are to have a gastric bypass to be intensively studied and followed by Rockefeller before and during the weight loss process.

Aims:

1. To study differential gene expression in fat tissue of subjects before and after weight loss using genechip microarray technology.
2. Tom study endocrine pathways that are involved in metabolic adaption to lower calorie intake and their response relation to changes in gene expression.Primary outcome of the study is change in gene expression following 10%, 20% weight loss and following weight stabilization. Secondary outcomes will be endocrine and behavioral parameters that will be monitored during the study. LABS1 participants would be asked if they are interested in this inpatient protocol and referred to Rockefeller for further explanation and consenting. LABS personnel screening < 2% of time. Dr. Strain serves as liaison on this project.
3. Data Collection Project for Weight Loss Surgery. (#0502007736)

3. Data Collection Project for Weight Loss Surgery. (#0502007736)

• PI: Alfons Pomp, MD
• Investigators: Drs. Dakin, Strain, Young, and Ebel
• All patients who receive weight loss surgery are asked for their permission to use their data on basic demographics, type of surgery, possible complications, quality of life issues and body composition prior to and following surgery for comparative purposes.
• All patients are consented for data collection and nothing is required of the patient other than their permission to use their basic data for comparative purposes.

4. Bariatric Surgery and its Effects on Bone Metabolism. (#0804-463)

• PI: Drs. Sinha and Strain
  Investigators: Drs. Pomp, Dakin, Bockman
• GCRC support
• Prior to and at intervals following bariatric procedures in 60 patients studies of bone health including wrist DEXAS, whole body DEXAS when possible and urine and blood studies of bone marker and vitamin D status are being completed.
• Dr. Sinha does all consenting in the GCRC. Dr. Strain serves as the liaison. LABS1 and LABS2 patients could participate in this project. Follow-up visits do correspond to LABS 2 protocol visits. Additional bloods are drawn, spot urine samples are obtained and a 5 minute questionnaire on calcium intake is completed.

5. Pilot Study of the Effect of Bariatric Surgery on Parameters of Reproductive Function in Obese Women (000502007762)

• PI: Vivian Sobel, MD
• Investigators: Drs. Imperato, Dakin, Pomp, Strain
• Supported by GCRC
• Questionnaires, hormone measurements and menstrual cycle data are being obtained from 150 morbidly obese women, ages 18-40, prior to and following bariatric surgical procedures.

Aims:

1. To examine the relationship between HPG axis function and leptin, ghrelin, and insulin levels in morbidly obese women and to correlate these levels with reproductive hormones (LH,FSH, SHBG, estradiol, androgens) and menstrual cyclicity. Levels will be compared between women with normal menses and those with menstrual irregularity or amenorrhea at baseline, during weight loss and after weight loss stablization.
2. To assess these hormones and menstrual cyclicity after weight loss in women undergoing each of the three bariatric procedures and to compare changes in hormonal levels and menstrual cyclicity between the three surgical groups. The degree of change in the number of the menstrual cycles/ month will be correlated with the extent and direction of change in the levels of leptin, ghrelin, and fasting insulin. Dr. Sobel will do all recruiting in the GCRC and be responsible for patient management. Dr. Strain will liaison on the project Drs. Imperato and Strain serve as mentors on the project.

6. Pilot Study of the Effect of Bariatric Surgery on Parameters of Reproductive Function in Obese Men. (000502007763)

• PI: Vivian Sobel, MD
• Investigators: Drs. Imperato, Dakin, Pomp, Strain
• Supported by GCRC
• Questionnaires, hormone measurements and semen analysis are being obtained from 50 morbidly obese men prior to and following bariatric surgical procedures.

Aims:

1. To examine the relationship between HPG axis function and leptin, ghrelin and insulin levels in morbidly obese men by correlating these levels with reproductive hormones (LH, FSH, SHBG, estradiol, androgens) and the following clinical parameters of reproductive function: semen analysis and sexual function.
2. To assess these hormones and reproductive parameters after weight loss in men undergoing each of three bariatric surgical procedures, and to compare changes in hormone levels and reproductive function between the three different surgical groups. Dr. Sobel will do all recruiting in the GCRC and be responsible for patient management. Dr. Strain will liaison on the project Drs. Imperato and Strain serve as mentors on the project.

7. Body Composition and REE Responses to Bariatric Surgeries

• PI: Dympna Gallagher
• NIH , DK 03-022 sub contract to Weill Cornell
• PI: Dr. Strain, Weill Cornell, No Weill Cornell IRB approval required.
• Investigators: Drs. Pomp, Dakin
• Consenting patients (50) will undergo multiple studies prior to and following bariatric procedures of body composition including measurements of total intracellular and extracellular body water, skeletal muscle mass, organ sizes, and bone mineral content using dilution techniques, MRI, and dual energy-X-ray absorptiometry.
• Screening only at Weill Cornell and referral to St. Lukes for consenting and studies. Dr. Strain, who was chairperson of the LABS BC work group, will liaison with the Body Composition Laboratory and be involved in patient follow-up, data analysis, and manuscript preparation

8. Blood Loss During Gastric Bypass with a 3.5mm vs 4.8mm Stapler (0509008103)

• PI: Alfons Pomp, MD, Weill Cornell
• Supported by US Surgical Tyco
• Investigators: Drs. Pomp, Dakin, and Strain

Surgeons providing consenting patients gastric bypasses will be randomly assigned to use a 3.5mm or a 4.8mm stapler for the procedure. Observations on blood loss and other complications will be recorded in hospital, at 1,4, and 8 weeks. The consenting 60 patients will only be required to permit their surgeon to use the randomly assigned stapler for their gastric bypass and have a 1 week follow-up visit with their surgeon which is not according to our current practice guidelines.

9. Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity (0509008122)

• PI: Emily Stein
• Supported by the GCRC
• Investigators: Bockman, Dakin, Pomp,Sinha, Strain.

For eight weeks prior to bariatric surgery 40 patients who are deficient in Vitamin D on initial evaluation will be randomly assigned two different forms of vitamin D and followed by blood and urine tests along with 20 other patients who do not have vitamin D deficiency. Since this study is planned for 8 weeks prior to surgery, these patients ideally might participate in LABS 2.

Aims:

1. To measure the ratio of PTH1-84 to 7-84 in cohorts of obese and normal weight subjects.
2. To measure changes in the ratio in obese subjects as vitamin D stores are repleted.
3. To measure the levels of 25 (OH) vitamin D after four and eight weeks of treatment with with either 8000 IU weekly of cholecalciferol or 50,000 IU weekly of ergocalciferol.

Dr. Stein does all the consenting in the GCRC. Dr. Strain serves as liaison on this Project. All patients requesting bariatric surgery routinely have vitamin D status evaluated as part of their initial clinical evaluation. As a practice guideline, if deficiency exists repletion is suggested prior to surgery. Patients participating in the protocol receive Vitamin D without cost.

Our Research Team

Please contact us with any questions you may have about our ongoing research and clinical trials listed above.

Gladys Strain, RD, PhD
Director of Research
Department of Surgery, Weight Loss Surgery Program

Email: gls2010@med.cornell.edu
Phone: (212) 746-5661
Fax: (212) 746-8680

Faith Ebel MPH, RD
Research Coordinator
Department of Surgery, Weight Loss Surgery Program

Email: fee2002@med.cornell.edu
Phone: (212) 746-5661
Fax: (212) 746-8680

Laura Young
Research Coordinator
Department of Surgery, Weight Loss Surgery Program

Email: lay2003@med.cornell.edu
Phone: (212) 746-5661
Fax: (212) 746-8680

Contact for bone metabolism study:

Naina Sinha, MD
Assistant Professor of Medicine
Department of Endocrinology, Diabetes & Metabolism

Email: sinhana@med.cornell.edu Phone: 212-746-6290