Clinical trial NCT00466882: Use of the INAMED LAPBAND System to Reduce BMI's in Obese Renal Failure Patients
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Renal Failure
Obesity
Keywords: obese
renal failure
renal transplant candidate
Hemodialysis BMI between 36 and 42
Lead sponsor: Summa Health System
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients undergoing peritoneal dialysis

Primary outcomes:
measure: Weight Loss
timeFrame: 2 years
Secondary outcomes:
measure: Transplantation Success
timeFrame: 2 years
Other outcomes:
Locations:
city: Akron
country: United States
facility: Summa Health System
state: Ohio
Study officials:
affiliation: Summa Health System
name: John Zografakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Summa Health System
name: Tanamay Lal, MD
role: PRINCIPAL_INVESTIGATOR
References: