- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00466882
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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Kontakter og lokationer
Studiesteder
-
-
Ohio
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Akron, Ohio, Forenede Stater, 44304
- Summa Health System
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 18 or older
- Hemodialysis patient with BMI between 36 and 42
Exclusion Criteria:
- Patients undergoing peritoneal dialysis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Weight Loss
Tidsramme: 2 years
|
Assess weight loss after surgery
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Transplantation Success
Tidsramme: 2 years
|
Assess possible effects of weight loss surgery on transplantation success
|
2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: John Zografakis, MD, Summa Health System
- Ledende efterforsker: Tanamay Lal, MD, Summa Health System
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- INAMED
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