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Trial record 34 of 400 for:    PYY

Gut Microbiota Post Roux-en-Y Gastric Bypass Surgery

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ClinicalTrials.gov Identifier: NCT02654496
Recruitment Status : Completed
First Posted : January 13, 2016
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Kristine Steffen, North Dakota State University

Brief Summary:
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.

Condition or disease Intervention/treatment
Obesity Other: Meal challenge

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Gut Microbiota in Patients Post Roux-en-Y Gastric Bypass Surgery
Study Start Date : January 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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. 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 ]

Biospecimen Description:
Fecal Samples and Plasma/Serum Samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
3-5 years post gastric bypass patients and control subjects
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654496


Locations
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United States, North Dakota
North Dakota State University/Sanford Health
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
North Dakota State University
Investigators
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Principal Investigator: Kristine Steffen, PharmD.,Ph.D North Dakota State University

Publications:
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Responsible Party: Kristine Steffen, Associate Professor, North Dakota State University
ClinicalTrials.gov Identifier: NCT02654496     History of Changes
Other Study ID Numbers: IRB-201509-061
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kristine Steffen, North Dakota State University:
Gut Microbiota
Weight Regain
Gastric Bypass