Bsnd studies looking for patients *(ie Free bands)

November 21, 2008

1. north carolina:

Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

This study is currently recruiting participants.

Verified by Central Carolina Surgery, PA, May 2006

Sponsors and Collaborators: Central Carolina Surgery, PA

EndoVx, Inc.

Information provided by: Central Carolina Surgery, PA

ClinicalTrials.gov Identifier: NCT00329862

Purpose

Laparoscopic Adjustable Gastric Banding (LAGB) is a gold standard in

the surgical treatment of morbid obesity. We hypothesize that the

addition of truncal vagotomy (cutting of nerves to the stomach) will

produce greater weight loss and better reduction of co-morbidities

(diseases caused by or aggravated by morbid obesity) than LAGB alone.

25 patients will be enrolled and outcomes compared to LAGB historical

controls over a post-operative period of 24 months.

Condition Intervention

Morbid Obesity

Obstructive Sleep Apnea

Hypertension

Urinary Incontinence

Hypertriglyceridemia

Diabetes

Hypercholesterolemia

Procedure: Laparoscopic Truncal Vagotomy

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol High Blood Pressure

Obesity Sleep Apnea Triglycerides Urinary Incontinence

Weight Control

U.S. FDA Resources

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Historical

Control, Single Group Assignment, Safety/Efficacy Study

Official Title: Pilot Study Assessing Advantage of Adding Truncal

Vagotomy to LAGB

Further study details as provided by Central Carolina Surgery, PA:

Primary Outcome Measures:

Excess body weight loss measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54,

60 weeks

BMI reduction measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks

Reduction and or elimination of co-morbidities @ 6, 12, 18, 24, 30,

36, 42, 48, 54, 60 weeks

Estimated Enrollment: 25

Study Start Date: May 2006

Estimated Study Completion Date: May 2006

Detailed Description:

The patients will receive standard laparoscopic adjustable gastric

banding treatment as well as truncal vagotomy. The vagus nerves will

be cut just below the diaphragm using the same access ports that are

used during the laparoscopic adjustable gastric banding. During the

surgical procedure, the first fifteen patients will also receive a

dose of Baclofen, a vagus nerve stimulant, and an endoscopy at the

end of the procedure during which congo red dye will sprayed within

the stomach. The Baclofen and endoscopy are used to ensure that all

branches of the vagus nerve have been cut. If, after 15 complete

vagotomies, are verified by the above testing then the use of

Baclofen and endoscopy will be abandoned.

Eligibility

Ages Eligible for Study: 18 Years to 60 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Male or female patient between 18 to 60 years of age.

Patient has body mass index (BMI) between 40 to 50 or a BMI between

35 to 40 with one or more co-morbidities , and a stable weight for

the last 3 months (+ 3 kg).

Female patients must be willing to use contraceptive methods during

the course of the trial (18 months).

Patient must be motivated to lose weight.

Patient has a history of at least one professionally supervised 6

month attempt to lose weight or more than two serious attempts.

Patient must be fully ambulatory.

Patient is to sign and be given a copy of the written informed

consent form. -

Exclusion Criteria:

History or signs of prior gastric or esophageal surgery

History of or signs and/or symptoms of gastro-duodenal ulcer disease.

Participation or plans for participation in another investigational

study during the study period.

Patients with large hiatal hernias. -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier:

NCT00329862

Contacts

Contact: Hardcastle, MD 336-387-8126

hardcastlek@...

Contact: Ellen Workman, BSN, MA 336.387.8133

mworkman2@...

Locations

United States, North Carolina

Wesley Long Community Hopital Recruiting

Greensboro, North Carolina, United States, 27410

Contact: Hardcastle, MD 336-286-0468

hardcastlek@...

Contact: Hardcastle, MD 336-286-0468

hardcastlek@...

Sponsors and Collaborators

Central Carolina Surgery, PA

EndoVx, Inc.

Investigators

Principal Investigator: Hardcastle, MD Central

Carolina Surgery, PA

More Information

Study ID Numbers: LAGBTV

First Received: May 23, 2006

Last Updated: May 23, 2006

ClinicalTrials.gov Identifier: NCT00329862

Health Authority: United States: Moses Cone IRB

Keywords provided by Central Carolina Surgery, PA:

Laparoscopic Adjustable Gastric Banding

Truncal Vagotomy

ClinicalTrials.gov processed this record on November 20, 2008

2. UC San diego:

Single Incision Laparoscopy (SIL)

This study is currently recruiting participants.

Verified by University of California, San Diego, February 2008

Sponsored by: University of California, San Diego

Information provided by: University of California, San Diego

ClinicalTrials.gov Identifier: NCT00616616

Purpose

Laparoscopic surgery being performed with only one small incision via

the umbilicus (belly button).

Condition Intervention

Appendicitis

Cholelithiasis

Malignant Hypertension

Procedure: single incision laparoscopic surgery

MedlinePlus related topics: Appendicitis Gallstones High

Blood Pressure

U.S. FDA Resources

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active

Control, Single Group Assignment, Safety/Efficacy Study

Official Title: Single Incision Laparoscopy

Further study details as provided by University of California, San

Diego:

Primary Outcome Measures:

Evaluate the safety and efficacy of single incision laparoscopy [

Time Frame: continuos ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30

Study Start Date: September 2007

Estimated Study Completion Date: September 2008

Estimated Primary Completion Date: September 2008 (Final data

collection date for primary outcome measure)

Arms Assigned Interventions

1: Experimental

all subjects Procedure: single incision laparoscopic surgery

Surgery will be performed with ine laparoscopic incision

Eligibility

Ages Eligible for Study: 18 Years to 75 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Ages 18-75

Patient has consented for a laparoscopic operation (independent of

study participation)

Attending surgeon decides operation can be completed via a single

incision laparoscopic approach

Exclusion Criteria:

Patients with BMI greater than 40

Minors and cognitively impaired individuals

Patients who are ASA class IV - Illness that is a constant threat to

life

Patients with ascites or Child's class C of liver failure

Patients with known common bile duct stones

Patients with coagulopathy, abnormal coagulation studies, or who take

heparin, coumadin, Plavix (clopidogrel), aspirin, or other medication

for the purpose of anti-coagulation and cannot be removed from the

medication prior to the operation.

Patients who present with incarcerated (irreducible) or strangulated

hernias

Patients with preoperative hematocrits less than 25.

Preoperative hematocrit less than 25.

Patients who have evidence of hemodynamic instability including

systolic blood pressure greater than 200 or less than 80.

Heart rate greater than 130 or less than 50. Respiratory rate greater

than 35 or less than 6. Patients who are on continuous pressor drip

for blood pressure support.

Patients who present for emergency adrenalectomy.

Patients with CT scan evidence of an abdominal abscess.

Patients who present 48 hours after the onset of abdominal pain

(appendectomy patients)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier:

NCT00616616

Contacts

Contact: Bosia, BSN 619-471-0447

misresearch@...

Locations

United States, California

University of California, San Diego Recruiting

San Diego, California, United States, 92103

Contact: Bosia, BSN 619-471-0447

misresearch@...

Principal Investigator: Santiago Horgan, MD

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator: Santiago Horgan, MD University of

California, San Diego

More Information

Responsible Party: University of California, San Diego ( Santiago

Horgan, MD )

Study ID Numbers: 071271

First Received: February 4, 2008

Last Updated: February 14, 2008

ClinicalTrials.gov Identifier: NCT00616616

Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:

appendectomy

cholecystectomy

gastric banding

adrenalectomy

Gastric lap-band placement

3. Ontario, Canada:

Laparoscopic Bariatric Surgery to Treat Type 2 Diabetes in Obese

Patients

This study is currently recruiting participants.

Verified by McMaster University, July 2007

Sponsored by: Hamilton Health Sciences

Information provided by: McMaster University

ClinicalTrials.gov Identifier: NCT00428571

Purpose

A large number of research studies on people who were morbidly obese

(extremely overweight), and had bariatric surgery (anti-obesity

surgery) have shown that patients who were diabetic before surgery

often experienced significant improvement in their diabetes following

the surgery. For some patients, blood glucose levels returned to the

normal range, and they were able to stop taking all of their diabetes

medications. For others, blood glucose levels improved, allowing them

to reduce their diabetes medications.

This research study is being done to determine whether bariatric

surgery can safely provide better control of diabetes symptoms in

obese diabetics than continuing medical management (anti-diabetic

drugs in combination with diet and lifestyle changes).

There are several different types of bariatric surgery currently

being used to treat morbid obesity. Two of the most common techniques

are gastric bypass and adjustable gastric banding. This study will be

comparing these two surgical techniques to treatment with a

combination of drugs, diet, and lifestyle changes for control of type

2 diabetes.

Condition Intervention

Type 2 Diabetes

Procedure: laparoscopic gastric bypass surgery

Procedure: laparoscopic adjustable gastric banding

Procedure: intensive medical management (medication, diet, lifestyle)

MedlinePlus related topics: Diabetes Obesity Weight Loss

Surgery

U.S. FDA Resources

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control,

Parallel Assignment, Safety/Efficacy Study

Official Title: Laparoscopic Bariatric Surgery for Treatment of

Type 2 Diabetes in Obese Patients With End Organ Damage: A

Prospective Randomized Controlled Pilot Study

Further study details as provided by McMaster University:

Primary Outcome Measures:

Diabetic control as assessed by HbA1c

Secondary Outcome Measures:

Resolution of diabetes

Improvement in diabetic control and cardio-metabolic profile

Weight loss and decrease in BMI

Reduction in the usage of insulin or other diabetic drugs

Improvement in diabetic complications and end-organ damage

Improvement in health-related quality of life and depression scores

Utilization of resources and productivity losses

Estimated Enrollment: 72

Study Start Date: May 2007

Eligibility

Ages Eligible for Study: 18 Years to 65 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Obese (BMI 30 # to < 40 kg/m2) patients who have had type 2 diabetes

mellitus for more than 5 years, complicated by at least one of the

following situations that persist despite adequate management

efforts. The complicating situations are:

Severely reduced quality of life as assessed by the Audit of Diabetes

Dependent Quality of Life (ADDQoL) questionnaire

Metabolic lability/instability, characterized by two or more episodes

of severe hypoglycemia (¡Ü 3mmol/L) or severe hyperglycemia (¡Ý 25

mmol/L), or two or more hospital visits for diabetic complications

over the last year

Despite efforts at optimal glucose control, progressive secondary

complications of diabetes as defined by:

Retinopathy ¡ª a minimum of a three step progression using the Early

Treatment Diabetic Retinopathy Study (ETDRS) grading system, or an

equivalent progression as certified by an ophthalmologist familiar

with diabetic retinopathy or

Nephropathy ¡ª persistent or progressive macroalbuminuria (>20 mg

albumin/mmol creatinine) over at least 12 months (beginning anytime

within the past two years) despite the use of an angiotensin-

converting enzyme (ACE) inhibitor or angiotensin II receptor blocker

(ARB) or

Neuropathy ¡ª persistent or progressing autonomic neuropathy

(gastroparesis, postural hypotension, neuropathic bowel or bladder)

or persistent or progressing severe peripheral painful neuropathy not

responding to usual management (e.g., tricyclics, gabapentin, or

carbamazepine)

Exclusion Criteria:

Less than 18 years of age or greater than 65 years of age

Unable to complete self and interviewer administered questionnaires

in English

Incapable of providing informed consent

Any of the following medical conditions that may be associated with

DM:

Recent positive history of myocardial infarction or coronary artery

bypass graft or percutaneous transluminal angioplasty (less than 6

months)

Unstable angina pectoris

Recent clinically important ST-T changes on electrocardiogram (ECG)

over the past year

Cardiac heart failure (New York Heart Association class III and IV;

ejection fraction < 50%)

Frequent and persistent and unstable supra and ventricular

arrhythmias,

Brain stroke, transient ischemic attack (TIA),

Major diabetic foot infections

Autonomic neuropathy resulting in orthostatic dysregulation

History of any psychiatric illness that would make the patient a poor

candidate for bariatric surgery, as determined by the study

psychiatrist

If female, pregnant or planning to become pregnant within next year

Clinically important cancer history (impact on either lifespan or

performance of lap. bariatric surgery)

Clinically important abdominal or thoracic surgery that would impact

the performance of laparoscopic bariatric procedure

Insulin dependence for more than 10 years

American Society of Anesthesiologists' classification of 4 or higher

Severe gastrointestinal reflux disease with Grade 3 or 4 esophagitis

History of pulmonary embolism or deep vein thrombosis

Presently taking either high-dose steroids or anticoagulants

Advanced nephropathy (Stage 4 or 5 ¨C eGFR less than 30 ml/min)

Any other condition that, in the opinion of the study surgeons, would

make the patient a poor candidate for bariatric surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier:

NCT00428571

Contacts

Contact: Barlow 905-522-1155 ext 35067

kbarlow@...

Locations

Canada, Ontario

St. ph's Healthcare Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Sub-Investigator: Arya M Sharma, MD

Sub-Investigator: H Goldsmith, PhD

Sub-Investigator: Monali Misra, MD

Sub-Investigator: Margherita Cadeddu, MD

Sub-Investigator: Gianluca Iacobellis, MD, PhD

Sub-Investigator: , MD

Sub-Investigator: Jean- Tarride, PhD

Principal Investigator: Mehran Anvari, MB BS, PhD

Sponsors and Collaborators

Hamilton Health Sciences

Investigators

Principal Investigator: Mehran Anvari, MB BS, PhD Centre

for Minimal Access Surgery, McMaster University

4. UC San diego:

Characteristics of Dendritic Cells Before and After Gastric Banding

This study is currently recruiting participants.

Verified by University of California, San Diego, February 2008

Sponsored by: University of California, San Diego

Information provided by: University of California, San Diego

ClinicalTrials.gov Identifier: NCT00488930

Purpose

A research study to find out more about a specific white blood cell

called a dendritic cell. These cells are found in a layer of fat in

the body called the omentum. The omentum is a layer of fat that

covers the bowels (intestines) and protects them.

The purpose of this study is to allow us to compare dendritic cells

in normal weight individuals to the dendritic cells of people who are

extremely overweight. These cells will be collected from the omentum,

the layer of fat that covers and protects the bowels (intestines),

from the mesentery, which is another layer of fat that surrounds the

intestines directly, and from the subcutaneous tissue, which is the

layer of fat just under the skin.

Condition Intervention

Morbid Obesity

Hyperglycemia

Diabetes Mellitus

Other: Observational

MedlinePlus related topics: Diabetes Obesity

U.S. FDA Resources

Study Type: Observational

Study Design: Case-Only, Prospective

Official Title: Characteristics of Dendritic Cells Before and After

Gastric Banding

Further study details as provided by University of California, San

Diego:

Primary Outcome Measures:

Measure changes in dendritic cells at baseline, 6 months and 1 year

following weight loss [ Time Frame: 1 year ] [ Designated as safety

issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment: 60

Study Start Date: June 2007

Estimated Study Completion Date: June 2008

Intervention Details:

Other: Observational

data collection ONLY

Show Detailed Description

Eligibility

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Sampling Method: Non-Probability Sample

Study Population

All subjects being treated for obesity at this institution

Criteria

Inclusion Criteria:

For gastric banding subjects to qualify for study inclusion, subjects

have to have a BMI ranging from 33-40. Currently a BMI of 33 is our

lower level of acceptable for bypass. Subjects with a BMI>40 will be

excluded because their fat cells are very large and therefore fragile

and unsuitable for research use.

Control Group:

All adult subjects 18 years or greater being seen in the minimally

invasive surgery clinic for elective laparoscopic surgery will also

be screened.

These will be subjects who are non-obese (BMI<30) and undergoing

laparoscopic surgery for a different indication such as hernia repair

or cholecystectomy. These will be patients who are undergoing

elective procedures to minimize the impact an acute inflamed abdomen

may have on the fat cells.

Exclusion Criteria:

Women who are pregnant or planning to become pregnant will be

excluded from this study. Gastric banding cannot not be performed on

pregnant women.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier:

NCT00488930

Locations

United States, California

UCSD Healthcare Recruiting

San Diego, California, United States, 92103

Contact: A Bosia, BSN 619-543-6544

jbosia@...

Contact: Chickering 619-471-0107

cechickering@...

Principal Investigator: Santiago Horgan, MD

Sub-Investigator: Jerrold M Olefsky, MD

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator: Santiago Horgan, MD UCSD

Study Director: Jerrold M Olefsky, MD UCSD

More Information

Responsible Party: University of California, San Diego ( Santiago

Horgan, MD )

Study ID Numbers: 070685, Internal Funding, NIH MED 1736

First Received: June 11, 2007

Last Updated: February 4, 2008

ClinicalTrials.gov Identifier: NCT00488930

Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:

Obesity

Hyperglycemia

Diabetes Mellitus Type I

Diabetes Mellitus Type II

Study placed in the following topic categories:

Obesity

Metabolic Diseases

Diabetes Mellitus

Endocrine System Diseases

Obesity, Morbid

Overweight

Body Weight

Signs and Symptoms

Hyperglycemia

Diabetes Mellitus, Type 2

Nutrition Disorders

Overnutrition

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 20, 2008

5. Cleveland clinic:

Glucose Metabolism in the Immediate and Short Term Follow up After

Bariatric Surgery (MIDAS)

This study is currently recruiting participants.

Verified by The Cleveland Clinic, June 2007

Sponsors and Collaborators: The Cleveland Clinic

Ethicon Endo-Surgery

Information provided by: The Cleveland Clinic

ClinicalTrials.gov Identifier: NCT00488423

Purpose

MIDAS involves an assessment of glucose levels obtained before and

after bariatric surgery. There are two different procedural tests

involved; an oral glucose tolerance test (mixed meal) and a

hyperglycemic clamp test. Two tests are performed preoperatively and

five more are performed postoperatively for a one year period. The

associated labwork drawn with the mixed meal and clamp tests are

demonstrating changes in glucose, insulin and gut hormone levels.

Condition Intervention Phase

Diabetes

Gastric Bypass

Procedure: Mixed Meal Tolerance test, Hyperglycemic clamp and

associated labwork

Phase I

MedlinePlus related topics: Diabetes Weight Loss Surgery

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type: Interventional

Study Design: Basic Science, Double-Blind, Uncontrolled, Single

Group Assignment, Efficacy Study

Official Title: Glucose Metabolism in the Immediate and Short Term

Follow up From Bariatric Surgery

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

To assess the effect of gastric by-pass surgery to decrease

lipotoxicity. [ Time Frame: One year ]

Secondary Outcome Measures:

To examine the effect of roux-en-Y compared to gastric banding on

pancreatic B cell recovery or insulin secretion in response to oral

and IV glucose. [ Time Frame: One Year ]

Estimated Enrollment: 4

Study Start Date: November 2006

Estimated Study Completion Date: November 2008

Detailed Description:

Tests performed are the Mixed Meal tolerance test, the Hyperglycemic

Clamp test, c-peptide, free fatty acids, adipocyte hormone profile

levels.

Eligibility

Ages Eligible for Study: 19 Years to 65 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Negative pregnancy test if female

ADA criteria for diabetes type II

Hematocrit > 35 creatinine < 1.9, AST < 3X upper limit of normal, ALT

< 3X upper limit of normal, alkaline phos <3X upper limit of normal

Eligibility for bariatric surgery based on the NIH and clinical

criteria

Mentally and legally capable of providing consent

Exclusion Criteria:

Lactating females

Must not have type I diabetes

Systemic steroids taken within 6 months

Clinically significant heart disease

Recent pulmonary embolism, untreated proliferative retinopathy, renal

failure, uncontrolled hypertension, autonomic neuropathy, resting

heart rate > 100, neuromuscular or musculoskeletal disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier:

NCT00488423

Contacts

Contact: L. Geither, RN 216-445-8461

geithec@...

Contact: Sidney Koepp, RN 216-444-8942 koepps@...

Locations

United States, Ohio

Cleveland Clinic Completed

Cleveland, Ohio, United States, 44195

Cleveland Clinic Recruiting

Cleveland, Ohio, United States, 44195

Contact: L. Geither, RN 216-444-2200 ext 58461

geithec@...

Sponsors and Collaborators

The Cleveland Clinic

Ethicon Endo-Surgery

Investigators

Principal Investigator: Sangeeta R. Kashyap, MD Cleveland

Clinic

Principal Investigator: Philip R. Schauer, M.D. Cleveland

Clinic

More Information

Study ID Numbers: 8585

First Received: June 18, 2007

Last Updated: November 7, 2007

ClinicalTrials.gov Identifier: NCT00488423

Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

diabetes

MIDAS

gut hormones

gastric bypass

lap band

6. columbia university

Changes in Insulin Sensitivity After Weight Loss

This study is currently recruiting participants.

Verified by National Institute of Diabetes and Digestive and Kidney

Diseases (NIDDK), August 2008

Sponsors and Collaborators: National Institute of Diabetes and

Digestive and Kidney Diseases (NIDDK)

Columbia University

Information provided by: National Institute of Diabetes and

Digestive and Kidney Diseases (NIDDK)

ClinicalTrials.gov Identifier: NCT00627484

Purpose

The main hypothesis of this study is that weight loss induced by

gastric bypass will induce a greater improvement in insulin

sensitivity compared with gastric banding or low calorie diet.

Subjects will be studied before and after weight loss by intravenous

glucose tolerance test and body composition will be measured by

magnetic resonance imaging.

Condition Intervention

Obesity, Type 2 Diabetes Mellitus, Insulin Resistance

Procedure: gastric bypass surgery

Behavioral: Liquid Diet

MedlinePlus related topics: Diabetes Obesity Weight

Control Weight Loss Surgery

Drug Information available for: Insulin

U.S. FDA Resources

Study Type: Interventional

Study Design: Basic Science, Open Label, Uncontrolled, Parallel

Assignment

Official Title: Changes in Insulin Sensitivity After Weight Loss

Induced by Diet or Bariatric Surgery

Further study details as provided by National Institute of Diabetes

and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Insulin Sensitivity [ Time Frame: 2-8 weeks ] [ Designated as safety

issue: No ]

Secondary Outcome Measures:

Body Composition [ Time Frame: 2-8 weeks ] [ Designated as safety

issue: No ]

Estimated Enrollment: 60

Study Start Date: August 2006

Estimated Study Completion Date: August 2010

Estimated Primary Completion Date: August 2010 (Final data

collection date for primary outcome measure)

Arms Assigned Interventions

1: Active Comparator

Gastric Bypass Surgery Procedure: gastric bypass surgery

gastric bypass surgery

2: Active Comparator

Liquid Diet Behavioral: Liquid Diet

Weight Loss with calorie restricted liquid diet

Eligibility

Ages Eligible for Study: 18 Years to 75 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

adults with or without diabetes undergoing gastric banding or gastric

bypass

obese adults with diabetes willing to undergo weight loss with a

liquid diet

Exclusion Criteria:

use of triglyceride lowering medication or weight loss medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier:

NCT00627484

Contacts

Contact: Gerardo Febres, MD 212-342-0281

Contact: Judith Korner, MD, PhD 212 305-3725

jk181@...

Locations

United States, New York

Columbia University Medical Center Recruiting

New York, New York, United States, 10032

Contact: Gerardo Febres, MD 212-342-0281

Contact: Judith Korner, MD, PhD 212 305-3725

jk181@...

Principal Investigator: Judith Korner, MD, PhD

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases

(NIDDK)

Columbia University

Investigators

Principal Investigator: Judith Korner, MD,PhD Columbia

University

More Information

Responsible Party: Columbia University ( Judith Korner, MD, PhD )

Study ID Numbers: 2401, DK072011

First Received: February 28, 2008

Last Updated: August 11, 2008

ClinicalTrials.gov Identifier: NCT00627484

Health Authority: United States: Institutional Review Board

Keywords provided by National Institute of Diabetes and Digestive and

Kidney Diseases (NIDDK):

Insulin resistance

Insulin sensitivity

bariatric surgery

diabetes

calorie restriction

body composition

Study placed in the following topic categories:

Obesity

Metabolic Diseases

Diabetes Mellitus

Endocrine System Diseases

Overweight

Insulin

Body Weight

Signs and Symptoms

Hyperinsulinism

Diabetes Mellitus, Type 2

Weight Loss

Body Weight Changes

Nutrition Disorders

Overnutrition

Endocrinopathy

Insulin Resistance

Metabolic disorder

Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Study placed in the following topic categories:

Diabetes Mellitus

ClinicalTrials.gov processed this record on November 20, 2008

7. TEEN study, U. of Illinois:

Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid

Obesity in Adolescents

This study is currently recruiting participants.

Verified by University of Illinois, December 2007

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Bsnd studies looking for patients *(ie Free bands)

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