NCT02884024

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

2.1 years

First QC Date

August 23, 2016

Last Update Submit

August 25, 2016

Conditions

Colorectal Cancer

Keywords

obesityinflammationcancer risk

Outcome Measures

Primary Outcomes (4)

  • colonic concentration of Tumor Necrosis Factor-alpha

    time zero: at baseline

  • colonic concentration of Interleukin-6

    time zero: at baseline

  • colonic concentration of Interleukin-1 beta

    time zero: at baseline

  • colonic concentration of Interferon-gamma

    time zero: at baseline

Study Arms (3)

lean

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

Other: no intervention

mildly obese

healthy subject undergoing routine screening colonoscopy, BMI 30-33.9

Other: no intervention

moderate-to-severe obese

healthy subject undergoing routine screening colonoscopy, BMI 34+

Other: no intervention

Interventions

no interventionOTHER

there is no intervention in this study

leanmildly obesemoderate-to-severe obese

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

43 generally healthy adults of both genders undergoing routine screening colonoscopy at Tufts Medical Center

You may qualify if:

  • Caucasian
  • undergoing clinically-indicated screening colonoscopy
  • BMI\< or = 25, or 30+

You may not qualify if:

  • past history of cancer (except non-melanoma skin cancer)
  • a polyposis syndrome
  • any current or chronic inflammatory disease or infection
  • incapable of providing valid informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsObesityInflammation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Nutrition

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 30, 2016

Study Start

January 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share