Weight Change, BodyBiobehavioralNCT03065426
Microbiome and Bariatric Surgery
An observational study of Weight Change, Body, run by North Dakota State University at 2 sites in United States.
Trial summary
This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify correlates and predictors of observed weight loss trajectories following bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Change, Body
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 May 2017to Sep 2021
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Participants planning to undergo Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.
Who may be able to join
- In evaluation for Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.
- Age 18-65, inclusive
Who cannot join
- Alcohol or substance use disorder in past year
- Severe psychiatric disorder that may affect ability to complete the protocol
- Regular tobacco use during the last year
- Current medication taken routinely and known to impact factors that may affect the gut microbiome
- Use of any oral or injectable antibiotic in the past month
- Use of commercially available pre/pro biotic in the past month
Show all 10Show fewer
- History of significant disease/disorder that would be expected to impact the microbiome of the gut
- Inability to engage in physical activity or dietary monitoring
- Nonprescribed/illicit drug use
- Pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Leslie Heinberg
Leslie Heinberg
- Recruiting
Neuropsychiatric Research Institute
Fargo, North Dakota, 58103
Brian Peterson
Kristine Steffen
About this study
Official title: Mechanisms That Predict Weight Trajectory After Bariatric Surgery: The Interactive Roles of Behavior and Biology
This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify correlates and predictors of observed weight loss trajectories following bariatric surgery. This approach will expand current knowledge by examining the combined impact of empirically supported behavioral and biological data in a large sample over time. Intensive measurement of problematic eating behaviors, mood, and compliance with diet and exercise regimens post-surgery will be analyzed in the context of lterations in parallel with, or in response to, changes observed in the gut microbiota. Identifying these post-surgical predictors of weight loss and comorbidity resolution will allow for the development of individualized interventions to optimize surgery-related outcomes.
- Conditions
- Weight Change, Body
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y Gastric Bypass | Patients planning to undergo Roux-en-Y Gastric Bypass will be invited to participate in this study. | |
| Sleeve Gastrectomy | Patients planning to undergo Sleeve Gastrectomy will be invited to participate in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight trajectory
Weight outcomes following bariatric surgery
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start11 May 2017
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight Change, BodyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- Neuropsychiatric Research Institute, The Cleveland Clinic
- Responsible party
- Principal investigator, Kristine Steffen, North Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065426
- Sponsor's protocol ID
- BIO-XXX
- Acronym
- Biobehavioral
- Status last verified
- May 2017
- First submitted
- 22 Feb 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: To the extent required by NIH and permitted by appropriate laws and rules. It will be available after the conclusion of the study and when the data have been cleaned.
Publications
Carroll I, Qian Y, Sorgen A, Steffen K, Heinberg L, Reed K, Malazarte A, Fodor A. Intestinal energy harvest is associated with post-bariatric surgery weight loss. Res Sq [Preprint]. 2024 Mar 29:rs.3.rs-4031151. doi: 10.21203/rs.3.rs-4031151/v1.
PubMed 38586018
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms That Predict Weight Trajectory After Bariatric Surgery: The Interactive Roles of Behavior and Biology
- ClinicalTrials.gov ID
- NCT03065426
- Acronym / sponsor ID
- Biobehavioral / BIO-XXX
- Conditions
- Weight Change, Body
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Collaborators
- Neuropsychiatric Research Institute, The Cleveland Clinic
- Study start
- 11 May 2017 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 27 Feb 2017 (actual)
- 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.
This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify correlates and predictors of observed weight loss trajectories following bariatric surgery. This approach will expand current knowledge by examining the combined impact of empirically supported behavioral and biological data in a large sample over time. Intensive measurement of problematic eating behaviors, mood, and compliance with diet and exercise regimens post-surgery will be analyzed in the context of lterations in parallel with, or in response to, changes observed in the gut microbiota. Identifying these post-surgical predictors of weight loss and comorbidity resolution will allow for the development of individualized interventions to optimize surgery-related outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y Gastric Bypass | – | –Patients planning to undergo Roux-en-Y Gastric Bypass will be invited to participate in this study. |
| Sleeve Gastrectomy | – | –Patients planning to undergo Sleeve Gastrectomy will be invited to participate in this study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants planning to undergo Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.
Key inclusion criteria (2 listed)
- In evaluation for Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.
- Age 18-65, inclusive
Key exclusion criteria (10 listed)
- Alcohol or substance use disorder in past year
- Severe psychiatric disorder that may affect ability to complete the protocol
- Regular tobacco use during the last year
- Current medication taken routinely and known to impact factors that may affect the gut microbiome
- Use of any oral or injectable antibiotic in the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight trajectory
Time frame: 24 months
Weight outcomes following bariatric surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Derived from this study: PubMed 38586018Carroll I, Qian Y, Sorgen A, Steffen K, Heinberg L, Reed K, Malazarte A, Fodor A. Intestinal energy harvest is associated with post-bariatric surgery weight loss. Res Sq [Preprint]. 2024 Mar 29:rs.3.rs-4031151. doi: 10.21203/rs.3.rs-4031151/v1.
- Individual participant dataSharing planned: Yes. To the extent required by NIH and permitted by appropriate laws and rules. It will be available after the conclusion of the study and when the data have been cleaned.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Change, Body, run by North Dakota State University at 2 sites 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carrie Nelson, BSN (701-365-4918, cnelson@nrifargo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight trajectory (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03065426, which also lists 1 linked publication.
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 16 May 2017.