Effects of Weight on Inflammation and Colon Cancer Risk

NCT ID: NCT02884024

Last Updated: 2016-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-02-28

Brief Summary

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An observational study designed to compare colonic cytokine concentrations in lean versus obese individuals

Detailed Description

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An observational study was performed on 43 individuals undergoing routine screening colonoscopy, some of whom were lean and some who were obese. They had weight, height, and waist-hip ratio measured at the time of colonoscopy and had additional colonic biopsies to measure colonic cytokines.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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lean

healthy subject undergoing routine screening colonoscopy, BMI\< or = 25

no intervention

Intervention Type OTHER

there is no intervention in this study

mildly obese

healthy subject undergoing routine screening colonoscopy, BMI 30-33.9

no intervention

Intervention Type OTHER

there is no intervention in this study

moderate-to-severe obese

healthy subject undergoing routine screening colonoscopy, BMI 34+

no intervention

Intervention Type OTHER

there is no intervention in this study

Interventions

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no intervention

there is no intervention in this study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Caucasian
2. undergoing clinically-indicated screening colonoscopy
3. BMI\< or = 25, or 30+

Exclusion Criteria

1. past history of cancer (except non-melanoma skin cancer)
2. a polyposis syndrome
3. any current or chronic inflammatory disease or infection
4. incapable of providing valid informed consent
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tufts Medical Center

OTHER

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Joel Mason

Professor of Medicine and Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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10103

Identifier Type: -

Identifier Source: org_study_id

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