Gut Microbiota Post Roux-en-Y Gastric Bypass Surgery

August 22, 2018 updated by: Kristine Steffen, North Dakota State University

The Gut Microbiota in Patients Post Roux-en-Y Gastric Bypass Surgery

The purpose of this study is to investigate mechanisms responsible for weight change in patients who have undergone weight loss surgery. Specifically, we will compare the gut microbiota, plasma bile acids, plasma gut peptides (GLP-1, GLP-2, and PYY), and plasma LPS in three groups of subjects: 3-5 years post gastric bypass patients who experienced sub-optimal weight loss, 3-5 years post gastric bypass patients who had successful weight loss, and a control group who has not had a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • North Dakota State University/Sanford Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

3-5 years post gastric bypass patients and control subjects

Description

Inclusion Criteria:

  • Female
  • Age 18-65
  • 3-5 years post Roux-en-Y gastric bypass and experienced successful weight loss following surgery (up to n=10) or
  • 3-5 years post Roux-en-Y gastric bypass and did not experience optimal weight loss following surgery (up to n=10) or
  • Nonsurgical control participants who are approximately matched in sex, age, and BMI to the optimal weight loss group (up to n=10).

Exclusion Criteria:

  • Tobacco use in past three months.
  • Taking a medication which is known to significantly influence gastrointestinal transit time or affect the microbiome or other variables significantly (as determined by study pharmacist/MD).
  • History of diabetes mellitus.
  • Has taken an oral or IV/IM antibiotic in the past 3 months.
  • Has taken probiotic and/or prebiotic agent in the past 3 months
  • History of significant intestinal disease or disorder (e.g., Crohn's disease, ulcerative colitis, irritable bowel syndrome)
  • History of gastrointestinal surgery that may impact measures of biological variables, as determined by the investigator.
  • Medical condition expected to impact the biological variables of interest or interfere with providing a sample, as determined by the investigator.
  • Unable to speak/read English.
  • Breastfeeding, pregnant, or planning to become pregnant within the duration of the study.
  • Unwilling to use a medically acceptable form of contraception.
  • History of bipolar or psychotic spectrum disorder or alcohol or substance treatment in the past year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 (Successful weight loss)
3-5 years post Roux-en-Y gastric bypass patients who had successful weight loss
Other: Meal challenge
Participants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected.
Group 2 (Suboptimal weight loss)
3-5 years post Roux-en-Y gastric bypass patients who had suboptimal weight loss
Other: Meal challenge
Participants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected.
Group 3 (Control group)
A control group who has not had Roux-en-Y gastric bypass surgery and are of similar age, gender, body mass index as the gastric bypass groups.
Other: Meal challenge
Participants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intestinal Microbiome Composition. The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.
Time Frame: 3-5 years post RYGB
3-5 years post RYGB

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma levels of cholic acid, chenodeoxy cholic acids, deoxycholic acid, and lithocholic acid will be measured by LCMS and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.
Time Frame: 3-5 years post RYGB
3-5 years post RYGB
Plasma levels of GLP-1, GLP-2, and PYY will be measured by ELISA and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.
Time Frame: 3-5 years post RYGB
3-5 years post RYGB
Plasma levels of Lipopolysaccharide (LPS) will be measured by the Limulus Amebocyte Lysate (LAL) assay and will be compared between successful weight loss and poor weigh loss post-RYGB and control groups.
Time Frame: 3-5 years post RYGB
3-5 years post RYGB

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Dakota State University

Investigators

  • Principal Investigator: Kristine Steffen, PharmD.,Ph.D, North Dakota State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 17, 2015

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-201509-061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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