We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of the INAMED LAPBAND System to Reduce BMI's in Obese Renal Failure Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00466882
First Posted: April 27, 2007
Last Update Posted: June 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John Zografakis, Summa Health System
  Purpose
The purpose of this study is to assess the use of this Lap-Band system for the purpose of promoting weight loss in renal failure patients who do not qualify as transplant candidates because of excessive BMI's

Condition Intervention
Renal Failure Obesity Device: Inamed Lap-Band System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Issues Related to the Use of the INAMED LAPBAND SYSTEM to Reduce BMI's in Obese Renal Failure Patients Needing Renal Transplantation: A Pilot Study

Further study details as provided by John Zografakis, Summa Health System:

Primary Outcome Measures:
  • Number of Participants With BMI < 35 kg/m^2 Within 18 Months Following Weight Loss Surgery [ Time Frame: 18 months ]
    See if successful weight loss surgery would allow patients to reduce their preoperative Body Mass Index (BMI in kg/m2) to below 35 kg/m2 within the first 18 months after weight loss surgery in order to see if these patients became eligible for kidney transplantation - most facilities require transplant candidates to have a BMI below 35 kg/m2.


Secondary Outcome Measures:
  • Document the Occurrence of Any Adverse Events Including Infection and/or Erosion of the LAPBAND and/or Need for Surgical Revision in LAPBAND [ Time Frame: Until recovery from transplant ]

Enrollment: 3
Study Start Date: October 2005
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Group 1 Inamed Lap-Band System
The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
Device: Inamed Lap-Band System
Patient's will be seen in the physician's office one week post surgery and once a month thereafter. The device can be gradually adjusted by the insertion of a needle into the port and saline is added or removed to inflate or deflate the LAPBAND. This can be conducted in the physician's office setting to enable the patient to lose 1-2 pounds per week over two.

Detailed Description:

The concern of transplant surgeons is that obese patients with high BMI's are more likely to experience post-transplantation complications than age-matched recipients [1]. Nevertheless, the Summa transplant list contains numerous patients with renal failure that have BMI's above 35. These patients are not considered to be "active" transplant candidates because of their obesity and are not eligible to receive a kidney transplant. Dr. Lal counsels these patients that they must lose weight in order to be considered active candidates for transplantation.

Weight loss for obese patients in renal failure is difficult. These patients must undergo hemodialysis three times weekly. Most of these patients do not, or physically cannot, engage in exercise activities. Many of these patients are burdened psychologically, and further behavioral responsibilities related to weight loss may overstress them. Repetitive diets or behavioral therapy in morbidly obese patients prior to transplantation have had disappointing results [2]. Likewise, pharmacological management of obesity in these patients is largely unsuccessful. Noradrenergic appetite suppressants must be restricted because of stimulatory side-effects. Serotonergic agents have cardiovascular and pulmonary complications. Thermogenic agents are minimally effective [2].

The INAMED LAPBAND SYSTEM is an FDA-approved, surgically-placed device marketed to facilitate weight reduction in obese individuals. The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years. These adjustments are performed on average 4-5 times during the first year and twice during the second year.

The purpose of this pilot study is to assess the utility of the LAPBAND in facilitating weight loss in obese renal failure patients awaiting transplantation and to document issues related to its use in these patients. The hope is that the LAPBAND will facilitate enough weight loss to reduce the patient's BMI to 35 or below after placement of the LAPBAND. If the patient reaches the intended goal of BMI of 35, they will be placed on the active renal transplant list and will be eligible for transplantation.

A secondary goal of this research is to follow those patients who successfully reach BMI's of 35 or less who are subsequently transplanted to determine any untoward effects of the LAPBAND upon transplantation success

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 or older
  • Hemodialysis patient with BMI between 36 and 42

Exclusion Criteria:

  • Patients undergoing peritoneal dialysis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466882


Locations
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Summa Health System
Investigators
Principal Investigator: John Zografakis, MD Summa Health System
Principal Investigator: Tanamay Lal, MD Summa Health System
  More Information

Responsible Party: John Zografakis, Staff Surgeon, Summa Health System
ClinicalTrials.gov Identifier: NCT00466882     History of Changes
Other Study ID Numbers: INAMED
First Submitted: April 26, 2007
First Posted: April 27, 2007
Results First Submitted: May 30, 2013
Results First Posted: June 1, 2015
Last Update Posted: June 1, 2015
Last Verified: May 2015

Keywords provided by John Zografakis, Summa Health System:
obese
renal failure
renal transplant candidate
Hemodialysis BMI between 36 and 42

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases