Defining the Role of the Gut Microbiome in Mediating the Effects of Obesity on Intestinal Stem Cells

NCT02863029 | Terminated DMC

• 1 other identifier: 16-003158
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

New studies are revealing how a high-fat diet could be making the cells of the intestinal lining more likely to become cancerous. The investigators would like to study how obesity influences growth of intestinal stem cells, which could then trigger intestinal tumors. The investigators are proposing a Pilot Study of 20 subjects (comprised of 10 participants from each of two different BMI categories: 20-25 and 35 \& above), who will be asked to provide blood, stool, \& urine samples, undergo a flexible sigmoidoscopy, and complete food frequency questionnaires

Conditions

Obesity

Keywords

Intestinal stem cells

Outcome Measures

Primary Outcomes (1)

• Changes in the growth of intestinal stem cells

  The gut microbiome is altered in obesity and studying intestinal stem cells will be helpful in learning what triggers intestinal tumors.

  Two years

Study Arms (1)

Flexible Sigmoidoscopy

OTHER

Participants will undergo an unsedated Flexible Sigmoidoscopy in order to obtain 12 mucosal biopsies. Serum cholesterol, triglyceride and HBA1C levels will be determined. Plasma, serum and whole blood will be stored for future use for next generation sequencing and metabolomics to determine the effect of different genetic loci on composition and function of gut microbiota

Procedure: Flexible Sigmoidoscopy

Interventions

Flexible Sigmoidoscopy PROCEDURE

A sigmoidoscopy is the minimally invasive medical examination of the large intestine from the rectum through the last part of the colon, using a flexible endoscope.

Flexible Sigmoidoscopy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants have a Body Mass Index (BMI) between 20-25 or 35 and above.
• Adults aged 18-65

You may not qualify if:

• Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions or diabetes mellitus
• Antibiotic use within the past 4 weeks (they can be enrolled after a four week washout period and subsequent use during the 6 month study duration does not exclude them)
• Bowel preparation for colonoscopy within the past week
• Significant bowel surgery other than hysterectomy or appendectomy
• Pregnancy or plans to become pregnant within the study time frame
• Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
• Age\<18 or vulnerable adults -

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

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

• Purna C Kashyap, M.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 11, 2016
• Study Start: January 1, 2017
• Primary Completion: March 9, 2017
• Study Completion: March 9, 2017
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)