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

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.
 
ClinicalTrials.gov Identifier: NCT00466882
Recruitment Status : Withdrawn (No patients were enrolled.)
First Posted : April 27, 2007
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
John Zografakis, Summa Health System

Brief Summary:
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 or disease Intervention/treatment
Renal Failure Obesity Device: Inamed Lap-Band System

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

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Retrospective
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
Actual Study Start Date : October 17, 2005
Estimated Primary Completion Date : November 2010
Actual Study Completion Date : January 24, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Group/Cohort Intervention/treatment
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 years.




Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 2 years ]
    Assess weight loss after surgery


Secondary Outcome Measures :
  1. Transplantation Success [ Time Frame: 2 years ]
    Assess possible effects of weight loss surgery on transplantation success



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with renal failure that have BMI's above 35 that would be a candidate for renal transplant if their BMI were 35 or less
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients undergoing peritoneal dialysis

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
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United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Summa Health System
Investigators
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Principal Investigator: John Zografakis, MD Summa Health System
Principal Investigator: Tanamay Lal, MD Summa Health System
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Responsible Party: John Zografakis, Staff Surgeon, Summa Health System
ClinicalTrials.gov Identifier: NCT00466882    
Other Study ID Numbers: INAMED
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Keywords provided by John Zografakis, Summa Health System:
obese
renal failure
renal transplant candidate
Hemodialysis BMI between 36 and 42
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases