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Effects of Weight on Inflammation and Colon Cancer Risk

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ClinicalTrials.gov Identifier: NCT02884024
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Collaborator:
Tufts Medical Center
Information provided by (Responsible Party):
Joel Mason, Tufts University

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

Condition or disease Intervention/treatment
Colorectal Cancer Other: no intervention

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study on the Effects of Weight on Inflammation and Colon Cancer Risk
Study Start Date : January 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Group/Cohort Intervention/treatment
lean
healthy subject undergoing routine screening colonoscopy, BMI< or = 25
Other: no intervention
there is no intervention in this study

mildly obese
healthy subject undergoing routine screening colonoscopy, BMI 30-33.9
Other: no intervention
there is no intervention in this study

moderate-to-severe obese
healthy subject undergoing routine screening colonoscopy, BMI 34+
Other: no intervention
there is no intervention in this study




Primary Outcome Measures :
  1. colonic concentration of Tumor Necrosis Factor-alpha [ Time Frame: time zero: at baseline ]
  2. colonic concentration of Interleukin-6 [ Time Frame: time zero: at baseline ]
  3. colonic concentration of Interleukin-1 beta [ Time Frame: time zero: at baseline ]
  4. colonic concentration of Interferon-gamma [ Time Frame: time zero: at baseline ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
43 generally healthy adults of both genders undergoing routine screening colonoscopy at Tufts Medical Center
Criteria

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

Responsible Party: Joel Mason, Professor of Medicine and Nutrition, Tufts University
ClinicalTrials.gov Identifier: NCT02884024     History of Changes
Other Study ID Numbers: 10103
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Joel Mason, Tufts University:
obesity
inflammation
cancer risk

Additional relevant MeSH terms:
Colorectal Neoplasms
Inflammation
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes