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The Association Between Areca-nut Chewing Habit and Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02175524
Recruitment Status : Unknown
Verified June 2014 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital

Brief Summary:
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.

Condition or disease
Oral and Esophageal Cancer Metabolic Syndrome.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : April 2014
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Metabolic syndrome [ Time Frame: Up to 1 week ]
    Measure blood pressure, blood lipid profiles, fasting glucose, and waist circumferences.


Secondary Outcome Measures :
  1. Antioxidant activity [ Time Frame: Up to 1 week ]
    Antioxidant ability measurements: lipid peroxidation markers (MDA), antioxidant enzymes activities (catalase, glutathione peroxidase, and superoxide dismutase).

  2. Inflammatory status [ Time Frame: Up to 1 week ]
    Measure inflammatory markers: C-reactive protein, Interleukin-6, and tumor necrosis factor-alpha.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with oral and oesophageal carcinoma.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175524


Contacts
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Contact: Ping-Ting Lin, Ph.D. +886-4-23470022 ext 12187 apt810@csmu.edu.tw
Contact: Bore-Jen Lee, Ph.D. +886-4-23592525 ext 3190 borjen@vghtc.gov.tw

Locations
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Taiwan
Taichung Verterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Ping-Ting Lin, Ph.D.    +886-24730022 ext 12187    apt810@csmu.edu.tw   
Contact: Bore-Jen Lee, Ph.D.    +886-23592525 ext 3190    borjen@vghtc.gov.tw   
Sponsors and Collaborators
Taichung Veterans General Hospital
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Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT02175524    
Other Study ID Numbers: CF13341
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Keywords provided by Taichung Veterans General Hospital:
nut chewing
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases