|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborators: |
National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01047735 |
Purpose
This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients.
T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus Obesity |
Procedure: Roux-en-Y Gastric Bypass Surgery Procedure: Laparoscopic Adjustable Gastric Banding Behavioral: Lifestyle Weight Loss Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Roux-en-Y Gastric Bypass Surgery |
Procedure: Roux-en-Y Gastric Bypass Surgery
Participants assigned to the Roux-en-Y Gastric Bypass study treatment group, will undergo a surgical procedure meant to limit food and fluid intake and cause nutrients malabsorption to promote weight loss. The surgeon will locate the stomach and small intestines laparoscopically through different tubes that are placed in the abdomen so that the stomach can be bypassed. The stomach will be stapled and divided or partitioned so that only a small section (able to hold 1 to 2 Tablespoons) will remain attached to the esophagus. The surgeon will then divide the small intestine a short distance from where it joins the stomach. The shorter segment leaving the stomach will be stapled to a portion of the undivided intestine. A long arm of the divided intestine will be brought up and stapled to the small portion of the stomach.
|
| Experimental: Laparoscopic Adjustable Gastric Banding |
Procedure: Laparoscopic Adjustable Gastric Banding
Those assigned to the Laparoscopic Adjustable Gastric Banding study group will undergo a surgical procedure where an adjustable silicone band is placed around the upper stomach to decrease its capacity so that you will feel full sooner. It will assist in weight loss by helping you to limit intake of calories. The band will be placed by using several small incisions and telescopic instruments. A thin tube connects the band to an access port just under the skin that you may be able to feel but you will not be able to see it. This allows the band to be tightened or loosened to decrease or increase your stomach capacity as needed. The surgery will take on average 30-45 minutes.
Other Name: LapBand
|
| Experimental: Lifestyle/Behavioral Weight Loss |
Behavioral: Lifestyle Weight Loss Intervention
Participants will receive a standard behavior weight control program in an in-person format over a period of 12 months conducted by an experienced team of weight loss counselors. During the initial 6 months of study treatment, will attend weekly in-person individual sessions with a weight loss counselor. During months 7-12, will attend in-person sessions on the 1st and 3rd week of the month and will receive a brief (less than 10 minutes in duration) telephone call on the 2nd and 4th week of the month. Each session will focus on a specific behavioral topic related to weight loss, eating behaviors, or exercise behaviors.
|
Eligibility| Ages Eligible for Study: | 25 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Magee-Womens Hospital of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Anita P Courcoulas, MD, MPH | University of Pittsburgh |
More Information
| Responsible Party: | Anita P. Courcoulas, MD, MPH, FACS/ Direction, Minimally Invasive Bariatric and General Surgery, University of Pittsburgh Medical Center |
| ClinicalTrials.gov Identifier: | NCT01047735 History of Changes |
| Other Study ID Numbers: | RC1DK086037, RC1DK086037 |
| Study First Received: | January 12, 2010 |
| Last Updated: | April 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
21+ years old Address Adult Amputation Area Arm Atheroscleroses Atherosclerosis Atherosclerotic Cardiovascular Disease Bariatrics Behavior Conditioning Therapy Behavior Modification Behavior Therapy Behavior Treatment |
Behavior or Life Style Modifications Behavioral Behavioral Conditioning Therapy Behavioral Modification Behavioral Therapy Behavioral Treatment Beta Cell Blindness Blood Pressure, High Blood Vessels Body Composition Body Weight decreased Cancers Cardiac infarction Cardiovascular Diseases |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |