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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018044
Receipt No. R000020900
Scientific Title Epidemiological study on the association between obesity and colorectal polyp/cancer in a Japanese population
Date of disclosure of the study information 2015/06/23
Last modified on 2018/10/16

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Basic information
Public title Epidemiological study on the association between obesity and colorectal polyp/cancer in a Japanese population
Acronym Obesity and colorectal polyp
Scientific Title Epidemiological study on the association between obesity and colorectal polyp/cancer in a Japanese population
Scientific Title:Acronym Obesity and colorectal polyp
Region
Japan

Condition
Condition Obesity, colorectal polyp
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the association between obesity and colorectal polyp from a perspective of gender difference
Basic objectives2 Others
Basic objectives -Others To evaluate the association between diabetes mellitus, dyslipidemia, insulin resistance oradiponectin and colorectal polyp
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between obesity and colorectal polyp from a perspective of gender difference
Key secondary outcomes Association between diabetes mellitus, dyslipidemia, insulin resistance or adiponectin and colorectal polyp

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undergo colonoscopy for the first time
Key exclusion criteria (1) Patients with a history of colectomy
(2) Patients who have determined by the physicians to have any reasons of unqualified
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jiro Watari
Organization Hyogo College of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya 663-8501, Japan
TEL 0798-45-6662
Email watarij@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jiro Watari
Organization Hyogo College of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya 663-8501, Japan
TEL 0798-45-6662
Homepage URL
Email watarij@hyo-med.ac.jp

Sponsor
Institute Jiro Watari
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Meiwa Hospital, Steel Memorial Hirohata Hospital
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30279628
Number of participants that the trial has enrolled
Results
The presence and number of adenomatous polyps (APs) were higher in men than in women (p=0.001 and p trend=0.0005, respectively). Large WC (OR=2.66, 95% CI=1.37-5.15, p=0.004) was an independent risk factor for APs in men, and high BMI (OR=2.86, 95% CI=1.10-7.44, p=0.03) and large WC (OR=3.59, 95% CI=1.37-9.42, p=0.009) were risk factors for APs in women. There were also significant differences in the colorectal cancer (CRC) risk factors between the sexes: alcohol drinking (OR=4.15, 95% CI=1.42-12.1, p=0.009) for men and family history of CRC (OR=7.47, 95% CI=1.82-30.7, p=0.005) for women. All adipose tissue-related biomarkers were significantly correlated with anthropometric measurements. The highest quartile of leptin concentrations had 3.07-fold (95% CI, 1.09-8.62, P =0.03) and 10.5-fold (95% CI, 1.08-102, P=0.02) increased AP and CRC risks compared with the lowest quartile only in men.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information There are sex differences in colorectal pathogenesis in a Japanese population. Visceral obesity and a high serum leptin level may be risk factors for colorectal neoplasms in Japanese men.

Management information
Registered date
2015 Year 06 Month 23 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020900

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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