Gut Microbiota Post Roux-en-Y Gastric Bypass Surgery

NCT ID: NCT02654496

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Group 1 (Successful weight loss)

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

Meal challenge

Intervention Type: OTHER

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

Meal challenge

Intervention Type: OTHER

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.

Meal challenge

Intervention Type: OTHER

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

Interventions

Meal challenge

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

North Dakota State University

OTHER

Sponsor Role: lead

Responsible Party

Kristine Steffen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristine Steffen, PharmD.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

North Dakota State University

Locations

North Dakota State University/Sanford Health

Fargo, North Dakota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24570244 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30604078 (View on PubMed)

Other Identifiers

IRB-201509-061

Identifier Type: -

Identifier Source: org_study_id