Severe ObesityNCT02128802
Obesity Surgery and Kidney Transplant for Patients With Obesity and Renal Failure
A study testing Gastric Bypass and Weight Loss Program in people with Severe Obesity and Renal Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Gastric Bypass followed by renal transplantation is superior to medical management followed by renal transplant for patients with severe obesity and renal failure. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Severe Obesity, Renal Failure
- What is being tested?
- Gastric Bypass and Weight Loss Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2014to 28 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index 40-55 kg/m2
- Age less than 60 years
- Available support person
- Adequate insurance
- All other criteria required for renal transplantation
Who cannot join
- Schizophrenia
- Bipolar disorder
- Crohn's disease
- Human Immunodeficiency Virus
- Cirrhosis
- Prior weight loss surgery
Show all 17Show fewer
- 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
- Previous renal transplant
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Weight Reduction Surgery Followed by Kidney Transplantation for Patients With Class III Obesity and Renal Failure
Gastric Bypass followed by renal transplantation is superior to medical management followed by renal transplant for patients with severe obesity and renal failure.
- Conditions
- Severe Obesity, Renal Failure
- Being tested
- Gastric Bypass, Weight Loss Program
- Keywords
- Obesity, Renal failure, Gastric bypass
- Medical subject headings
- Obesity, Morbid, Renal Insufficiency, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric BypassProcedure or surgery
Weight Loss ProgramOther
| Study group | Role | What they receive |
|---|---|---|
| Surgical Gastric Bypass | Experimental | Patients will undergo surgical gastric bypass according to standard institutional protocols Receives: Procedure: Gastric Bypass |
| Medical Weight Loss Management | Experimental | Patients will receive best practices medical management for weight loss under current institutional protocols Receives: Other: Weight Loss Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (8)
All-cause mortality
Number of patients who die from any cause
Measured: 5 years
Weight loss
Amount of weight lost at various points over the study period
Measured: 5 years
Surgical outcomes
Incidence of surgical complications including but not limited to leak rate, stricture rate, pulmonary embolism, and infection.
Measured: 5 years
Development or regression of diabetes
Including but not limited to start of stop of insulin therapy, amount of insulin required, and start or stop of or cal medications.
Measured: 5 years
Development or regression of other comorbidities
Development or regression of other diseases including but not limited to hypertension, coronary artery disease, and skin infections.
Measured: 5 years
Health care utilization
This outcome measure includes but is not limited to the amount of money spent on health care, total hospitalization, days of hospitalization, and procedures required.
Measured: 5 years
Nutritional status
This outcome includes but is not limited to measures of albumin, pre-albumin, and caloric intake.
Measured: 5 years
Hormonal and metabolic status
This outcome includes but is not limited to measurement of protein catabolism, creatinine clearance, and serum prealbumin. In addition, protein and iron metabolism will be measured using serum albumin, transferrin and ferritin. Glucose metabolism will be measured by glucose and insulin levels. regression of the disease. Lipid metabolism will be assessed with triglyceride levels, very-low density lipoproteins, and cholesterol. Micronutrient levels will be measured with vitamin D, thiamin, B12, and folate.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study start1 Apr 2014
- Primary completion29 Jun 2021
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Karp, Vanderbilt University Medical Center
- Investigators
- Seth Karp, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128802
- Sponsor's protocol ID
- 130912
- Status last verified
- Mar 2025
- First submitted
- 23 Apr 2014
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Reduction Surgery Followed by Kidney Transplantation for Patients With Class III Obesity and Renal Failure
- ClinicalTrials.gov ID
- NCT02128802
- Acronym / sponsor ID
- 130912
- Conditions
- Severe Obesity, Renal Failure
- Keywords
- Obesity, Renal failure, Gastric bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric Bypass followed by renal transplantation is superior to medical management followed by renal transplant for patients with severe obesity and renal failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Gastric Bypass | Experimental | Procedure: Gastric BypassPatients will undergo surgical gastric bypass according to standard institutional protocols |
| Medical Weight Loss Management | Experimental | Other: Weight Loss ProgramPatients will receive best practices medical management for weight loss under current institutional protocols |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index 40-55 kg/m2
- Age less than 60 years
- Available support person
- Adequate insurance
- All other criteria required for renal transplantation
Key exclusion criteria (17 listed)
- Schizophrenia
- Bipolar disorder
- Crohn's disease
- Human Immunodeficiency Virus
- Cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric Bypass | Procedure or surgery | Surgical Gastric Bypass |
| Weight Loss Program | Other | Medical Weight Loss Management |
Primary outcome
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)
Time frame: 18 months
Outcomes will be measured based on weight loss and a variety of validated surveys and questionnaires to measure HRQOL
8 secondary outcomes
All-cause mortality
Time frame: 5 years
Weight loss
Time frame: 5 years
Surgical outcomes
Time frame: 5 years
Development or regression of diabetes
Time frame: 5 years
Development or regression of other comorbidities
Time frame: 5 years
Health care utilization
Time frame: 5 years
Nutritional status
Time frame: 5 years
Hormonal and metabolic status
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Karp, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Bypass and Weight Loss Program in people with Severe Obesity and Renal Failure, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.