- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02175524
The Association Between Areca-nut Chewing Habit and Metabolic Syndrome
June 24, 2014 updated by: Taichung Veterans General Hospital
The purpose of this study is going to determine the odds ratio of metabolic syndrome (MS), the habit of areca nut chewing, antioxidant, and inflammatory status in oral and esophageal patients.
The current study was designed as a case-control study.
Patients proved to be oral and esophageal cancer and had the habit of areca nut chewing are defined as case group.
Patients proved to be oral and esophageal cancer and did not have the habit of areca nut chewing are defined as control group.
The participants' age, blood pressures, and smoking habits will be recorded.
Body weight, height, waist, and hip circumferences will be measured.
Fasting venous blood samples will be obtained to determine hematological parameters [i.e., serum creatinine, total cholesterol, triacylglycerol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, malondialdehyde, superoxide dismutase, glutathione peroxidase, catalase, and inflammatory markers (C-reactive protein, tumor necrosis factor-alpha, and interleukin-6)].
Logistic regression analyses are going to perform to examine the relationship between areca nut chewing and MS in this population.
If we can make sure the relationship between areca nut chewing and MS, the clinicians and nutritionists can teach people to quit areca nut chewing in order to avoid the possibility of developing metabolic syndrome and cardiovascular disease.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taichung, Taiwan, 40705
- Recruiting
- Taichung Verterans General Hospital
-
Contact:
- Ping-Ting Lin, Ph.D.
- Phone Number: 12187 +886-24730022
- Email: apt810@csmu.edu.tw
-
Contact:
- Bore-Jen Lee, Ph.D.
- Phone Number: 3190 +886-23592525
- Email: borjen@vghtc.gov.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with oral and oesophageal carcinoma.
Description
Inclusion Criteria:
- Patients proved to be oral and esophageal cancer will be recruited.
Exclusion Criteria:
- Subjects with diabetes mellitus, liver, renal diseases, or undergoing statin therapy.
- Taking antioxidant vitamins supplements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Case
Patients proved to be oral and esophageal cancer and had the habit of areca nut chewing.
|
|
Control
Patients proved to be oral and esophageal cancer and did not have the habit of areca nut chewing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolic syndrome
Time Frame: Up to 1 week
|
Measure blood pressure, blood lipid profiles, fasting glucose, and waist circumferences.
|
Up to 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antioxidant activity
Time Frame: Up to 1 week
|
Antioxidant ability measurements: lipid peroxidation markers (MDA), antioxidant enzymes activities (catalase, glutathione peroxidase, and superoxide dismutase).
|
Up to 1 week
|
|
Inflammatory status
Time Frame: Up to 1 week
|
Measure inflammatory markers: C-reactive protein, Interleukin-6, and tumor necrosis factor-alpha.
|
Up to 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
June 24, 2014
First Submitted That Met QC Criteria
June 24, 2014
First Posted (Estimate)
June 26, 2014
Study Record Updates
Last Update Posted (Estimate)
June 26, 2014
Last Update Submitted That Met QC Criteria
June 24, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF13341
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oral and Esophageal Cancer
-
National Cancer Institute (NCI)WithdrawnCervical Carcinoma | Recurrent Melanoma | Vaginal Carcinoma | Esophageal Carcinoma | Mucosal Melanoma | Mucosal Melanoma of the Head and Neck | Oral Cavity Mucosal Melanoma | Stage II Vulvar Cancer AJCC v7 | Stage III Vulvar Cancer AJCC v7 | Stage IIIA Vulvar Cancer AJCC v7 | Stage IIIB Vulvar Cancer AJCC v7 and other conditionsUnited States
-
Anil ChaturvediNational Taiwan University HospitalRecruitingOral Cancer | Oral Cancer Screening | Oral PrecancerTaiwan
-
Royal Surrey County Hospital NHS Foundation TrustCompleted
-
National Taiwan University HospitalCompleted
-
King's College LondonGuy's and St Thomas' NHS Foundation TrustNot yet recruitingOral Cancer | Dysplasia | Mouth Cancer | Oral Lesions | Oral Pre-cancerUnited Kingdom
-
Thompson Cancer Survival CenterCompletedEffects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and EsophagitisLaryngeal Cancer | Esophageal Cancer | Oropharynx Cancer | Oral Cavity Cancer | Mediastinal Cancer | Head and Neck Cancers - Tonsils | Chest Wall Tumor | Radiation MucositisUnited States
-
Combined Military Hospital, PakistanNational University of Medical Sciences, PakistanCompletedOral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity CancerPakistan
-
University of WashingtonBlaze Bioscience Inc.TerminatedStage III Lip and Oral Cavity Cancer AJCC v8 | Oral Cavity Squamous Cell Carcinoma | Stage I Lip and Oral Cavity Cancer AJCC v8 | Stage II Lip and Oral Cavity Cancer AJCC v8 | Stage IVA Lip and Oral Cavity Cancer AJCC v8United States
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnStage IIB Esophageal Cancer AJCC v7 | Stage III Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7
-
National Cancer Institute (NCI)NRG OncologyCompletedEsophageal Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IB Esophageal Cancer AJCC v7United States