Gut Microbiota Post Roux-en-Y Gastric Bypass Surgery

North Dakota State University

Status: Completed

Conditions: Obesity

Treatments: Other: Meal challenge

Study type: Observational

Funder types: Other

Identifiers

NCT02654496

IRB-201509-061

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

19 participants in 3 patient groups

Group 1 (Successful weight loss)

Description:

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

Treatment:

Other: Meal challenge

Group 2 (Suboptimal weight loss)

Description:

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

Treatment:

Other: Meal challenge

Group 3 (Control group)

Description:

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.

Treatment:

Other: Meal challenge