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| Name | Class |
|---|---|
| Seguros Caracas Foundation | UNKNOWN |
| National Fund for Science and Technology, Science Mission | UNKNOWN |
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Since diabetes has multiple etiologies and oxidative stress one of the proposed mechanisms, the objective is to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.
Type 2 diabetes is a chronic, multifactorial disease, and oxidative stress one of the pathophysiological mechanisms associated with its appearance and development. The objective was to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.
A total of 117 volunteers participated in the study. Type 2 diabetics (34) and healthy individuals (24), received 6 mg β-carotene for 45 d, and were compared to similar non-supplemented diabetic (33) and control (26) groups. Blood samples were taken at the beginning, end and 30 days after finishing supplementation, to determine hemoglobin, hematocrit unsaturated iron binding capacity, total iron binding capacity, transferrin saturation, ferritin, glycemia, glycosylated hemoglobin, cholesterol, triglycerides, HDL, LDL, oxidized LDL, copper, zinc, TBARS, FRAP, nitrites, GPx, SOD, folates, retinol and β-carotene.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemented Diabetics (DB) | Experimental | Diabetics supplemented with betacarotene for 45 days |
|
| Unsupplemented Diabetics (DS) | Experimental | Diabetics without betacarotene supplementation |
|
| Supplemented Controls (CB) | Active Comparator | Controls supplemented with betacarotene for 45 days |
|
| Unsupplemented Controls (CS) | Active Comparator | Controls without betacarotene supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betacarotene | Dietary Supplement | 6 mg betacarotene in caplets for 45 days (daily)and reevaluate parameters 30 days after finishing supplementation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in oxidative status | Time 0, 45 days and 75 days after supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin and hematocrit | Time 0, 45 days and 75 days after supplementation | |
| Ferritin | Enzyme linked immunosorbent assay (ELISA) with monoclonal antibodies | Time 0, 45 days and 75 days after supplementation |
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Inclusion Criteria:
Patients with a diagnose of Type 2 diabetes mellitus of at least 5 years of diagnosis, in treatment with oral hypoglycemics Patients in regular control (once a month) in the Hospital
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria N Garcia-Casal, PhD | Instituto Venezolano de Investigaciones Cientificas | Study Director |
| Jose M Moreno, PhD | Instituto Venezolanode Investigaciones cientificas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Baudilio Lara | Barquisimeto | Lara | Venezuela |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10587829 | Background | Ford ES, Cogswell ME. Diabetes and serum ferritin concentration among U.S. adults. Diabetes Care. 1999 Dec;22(12):1978-83. doi: 10.2337/diacare.22.12.1978. | |
| 12941775 | Background | Ford ES, Mokdad AH, Giles WH, Brown DW. The metabolic syndrome and antioxidant concentrations: findings from the Third National Health and Nutrition Examination Survey. Diabetes. 2003 Sep;52(9):2346-52. doi: 10.2337/diabetes.52.9.2346. |
| Label | URL |
|---|---|
| American Diabetes Association | View source |
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|
| Controls. No treatment | Dietary Supplement | Evaluate at time 0, 45 days and 75 days, but without receiving betacarotene supplements |
|
|
| Iron metabolism markers | Serum iron, total iron binding capacity (TIBC) and unsaturated iron binding capacity (UIBC) were determined by the methods proposed by the International Committee of Standardization of Hematology. | Time 0, 45 days and 75 days after supplementation |
| Blood Chemistry | Glycemia, triglycerides, total cholesterol, LDL, and HDL were determined automatically in a Ciba Corning 550 Express autoanalizer, using classic enzymatic methods for the determination of these variables. | Time 0, 45 days and 75 days after supplementation |
| Glycosylated Hemoglobin | It was determined using a commercial kit (Bioscience, Caracas, Venezuela), | Time 0, 45 days and 75 days after supplementation |
| Oxidized LDL | Analyzed by a solid phase two-site enzyme immunoassay from Mercodia (Sweden), which contains 2 monoclonal antibodies directed against separated antigenic determinants on the oxidized apolipoprotein B molecule. | Time 0, 45 days and 75 days after supplementation |
| Thiobarbituric Acid Reactive substances (TBARS) | Were detected by the quantification of malondialdehyde present in the sample, by reacting 2 molecules of thiobarbituric acid with 1 molecule of malondialdehyde, which produces an abduct that is detected at 535 mn. | Time 0, 45 days and 75 days after supplementation |
| Ferric Reducing ability of Plasma (FRAP). | Measured after 4 and 10 min incubation, was used to determine the ability of plasma to reduce iron from ferric to ferrous state, based on the formation of a triazine-Fe+3 complex, that when reduced to Fe+2, generate a change in color that is measured at 593 nm. | Time 0, 45 days and 75 days after supplementation |
| Activities of the enzymes superoxide dismutase (SOD) and glutathione peroxidase (GPx). | Determined by commercial kits (Cayman Chemicals, Pittsburg) following the recommended protocols | Time 0, 45 days and 75 days after supplementation |
| Serum zinc and copper. | By flame atomic absorption spectrophotometry | Time 0, 45 days and 75 days after supplementation |
| β-carotene. | It was determined by HPLC, with a reverse fase C18 column. | Time 0, 45 days and 75 days after supplementation |
| Serum retinol | It was determined by HPLC, with a reverse fase C18 column, as an indirect measure of betacarotene metabolism. | Time 0, 45 days and 75 days after supplementation |
| Serum nitrites | Were determined as an indirect measure of the concentration of nitric oxide, since nitrites are the stable end products of its degradation. Nitrates were reduced to nitrites by activated cadmium. Then sulfanilamide and nitrites generate a chromophore that reacts with naftilethylenediamine, to generate a product visible at 540 nm. | Time 0, 45 days and 75 days after supplementation |
| Serum and erythrocyte folates. | The method is based in the folate-dependent controlled growth of a Lactobacillus strain that is measured spectrophotometrically and quantified against a standard curve. | Time 0, 45 days and 75 days after supplementation |
| 16537987 | Background | Sugiura M, Nakamura M, Ikoma Y, Yano M, Ogawa K, Matsumoto H, Kato M, Ohshima M, Nagao A. The homeostasis model assessment-insulin resistance index is inversely associated with serum carotenoids in non-diabetic subjects. J Epidemiol. 2006 Mar;16(2):71-8. doi: 10.2188/jea.16.71. |
| 19491386 | Background | Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE. Effects of vitamins C and E and beta-carotene on the risk of type 2 diabetes in women at high risk of cardiovascular disease: a randomized controlled trial. Am J Clin Nutr. 2009 Aug;90(2):429-37. doi: 10.3945/ajcn.2009.27491. Epub 2009 Jun 2. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D019189 | Iron Metabolism Disorders |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019207 | beta Carotene |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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