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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Renal Failure
• Intervention / Treatment: 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

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients undergoing peritoneal dialysis

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss	Assess weight loss after surgery	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transplantation Success	Assess possible effects of weight loss surgery on transplantation success	2 years

Collaborators and Investigators

• Sponsor: Summa Health System
• Investigators: Principal Investigator: John Zografakis, MD, Summa Health System; Principal Investigator: Tanamay Lal, MD, Summa Health System

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2005
• Primary Completion (Anticipated): November 1, 2010
• Study Completion (Actual): January 24, 2011

Study Registration Dates

• First Submitted: April 26, 2007
• First Submitted That Met QC Criteria: April 26, 2007
• First Posted (Estimate): April 27, 2007

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: renal failure; obese; renal transplant candidate; Hemodialysis BMI between 36 and 42
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: INAMED