NCT02128802

Brief Summary

Gastric Bypass followed by renal transplantation is superior to medical management followed by renal transplant for patients with severe obesity and renal failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2024

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

7.2 years

First QC Date

April 23, 2014

Last Update Submit

March 5, 2025

Conditions

Severe ObesityRenal Failure

Keywords

ObesityRenal failureGastric bypass

Outcome Measures

Primary Outcomes (1)

  • Ability to reach medical suitability for renal transplant within 18 months after initiating treatment and the change and trajectory of health-related quality of life (HRQOL)

    Outcomes will be measured based on weight loss and a variety of validated surveys and questionnaires to measure HRQOL

    18 months

Secondary Outcomes (8)

  • All-cause mortality

    5 years

  • Weight loss

    5 years

  • Surgical outcomes

    5 years

  • Development or regression of diabetes

    5 years

  • Development or regression of other comorbidities

    5 years

  • +3 more secondary outcomes

Other Outcomes (1)

  • Prograf dosing

    5 years

Study Arms (2)

Surgical Gastric Bypass

EXPERIMENTAL

Patients will undergo surgical gastric bypass according to standard institutional protocols

Procedure: Gastric Bypass

Medical Weight Loss Management

EXPERIMENTAL

Patients will receive best practices medical management for weight loss under current institutional protocols

Other: Weight Loss Program

Interventions

Gastric BypassPROCEDURE
Surgical Gastric Bypass
Weight Loss ProgramOTHER
Medical Weight Loss Management

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index 40-55 kg/m2
  • Age less than 60 years
  • Available support person
  • Adequate insurance
  • All other criteria required for renal transplantation

You may not qualify if:

  • Schizophrenia
  • Bipolar disorder
  • Crohn's disease
  • Human Immunodeficiency Virus
  • Cirrhosis
  • Prior weight loss surgery
  • Prior mesh hernia repair
  • Prior anti-reflux surgery
  • Inability to walk 200 feet
  • Significant coronary disease
  • Significant lung disease - Fixed expiratory volume 1 less than 75% or on oxygen
  • Addiction to alcohol or drugs
  • Inability to quit smoking
  • Jehovah's witness
  • Non-compliance with dialysis regimen
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Obesity, MorbidRenal InsufficiencyObesity

Interventions

Gastric BypassWeight Reduction Programs

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical ProceduresHealth PromotionHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Seth Karp, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2014

First Posted

May 1, 2014

Study Start

April 1, 2014

Primary Completion

June 29, 2021

Study Completion

March 28, 2024

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations

US(1)