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

This study has been completed.
Sponsor:
Information provided by:
Summa Health System
ClinicalTrials.gov Identifier:
NCT00466882
First received: April 26, 2007
Last updated: May 30, 2012
Last verified: May 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Summa Health System:

Primary Outcome Measures:
  • Assess weight loss in obese subjectsfor potential kidney transplant [ Time Frame: Until subject recovers from transplant or does not qualify ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: October 2005
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Inamed Lap-Band System
    Used to reduce body weight fro further surgery.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: John Zografakis, M.D., Summa Health System
ClinicalTrials.gov Identifier: NCT00466882     History of Changes
Other Study ID Numbers: INAMED
Study First Received: April 26, 2007
Last Updated: May 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on October 22, 2014