Metabolic Syndrome. Clinical Trial
| NCT number | NCT02175524 |
| Other study ID # | CF13341 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | June 24, 2014 |
| Last updated | June 24, 2014 |
| Start date | April 2014 |
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Taichung Verterans General Hospital | Taichung |
| Lead Sponsor | Collaborator |
|---|---|
| Taichung Veterans General Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Metabolic syndrome | Measure blood pressure, blood lipid profiles, fasting glucose, and waist circumferences. | Up to 1 week | No |
| Secondary | Antioxidant activity | Antioxidant ability measurements: lipid peroxidation markers (MDA), antioxidant enzymes activities (catalase, glutathione peroxidase, and superoxide dismutase). | Up to 1 week | No |
| Secondary | Inflammatory status | Measure inflammatory markers: C-reactive protein, Interleukin-6, and tumor necrosis factor-alpha. | Up to 1 week | No |