Gut Microbiota Post Roux-en-Y Gastric Bypass Surgery

NCT02654496 | Completed DMC

• 1 other identifier: IRB-201509-061
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Gut Microbiota; Weight Regain; Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• Intestinal Microbiome Composition. The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.

  3-5 years post RYGB

Secondary Outcomes (3)

• 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.

  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.

  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.

  3-5 years post RYGB

Study Arms (3)

Group 1 (Successful weight loss)

3-5 years post Roux-en-Y gastric bypass patients who had successful weight loss

Other: Meal challenge

Group 2 (Suboptimal weight loss)

3-5 years post Roux-en-Y gastric bypass patients who had suboptimal weight loss

Other: Meal challenge

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

Interventions

Meal challenge OTHER

Participants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected.

Group 1 (Successful weight loss); Group 2 (Suboptimal weight loss); Group 3 (Control group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

3-5 years post gastric bypass patients and control subjects

You may qualify if:

• Female
• Age 18-65
• years post Roux-en-Y gastric bypass and experienced successful weight loss following surgery (up to n=10) or
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• North Dakota State University: lead

Study Sites (1)

North Dakota State University/Sanford Health

Fargo, North Dakota, 58103, United States

Location

Related Publications (2)

• Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.

  PMID: 24570244 BACKGROUND

• Fouladi F, Brooks AE, Fodor AA, Carroll IM, Bulik-Sullivan EC, Tsilimigras MCB, Sioda M, Steffen KJ. The Role of the Gut Microbiota in Sustained Weight Loss Following Roux-en-Y Gastric Bypass Surgery. Obes Surg. 2019 Apr;29(4):1259-1267. doi: 10.1007/s11695-018-03653-y.

  PMID: 30604078 DERIVED

Biospecimen

Fecal Samples and Plasma/Serum Samples

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristine Steffen, PharmD.,Ph.D

  North Dakota State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: January 13, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)