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Type 2 Diabetes Mellitus According to the World Health Organization (WHO), there are more than 346 million individuals with diabetes, of which 90% are type 2. Global estimations for the year 2030 predict an epidemic increase that will reach 366 million. According to the National Nutrition and Health Survey of 2006 (ENSANUT2005), there are 6.4 million type 2 diabetic subjects in Mexico.
According to the calculation of the sample size, the investigators will include 120 adults with type 2 diabetes mellitus selected from the outpatient preventive medicine offices of health centres in the State of Mexico who will divided in two groups: supplement and placebo (60 per group). After having been invited to participate and obtaining the informed consent, study subjects will be evaluated for dietary information, as well as biochemical biomarkers of metabolic control, anthropometric, immune and inflammatory markers, gut microbiota and oxidative stress, before beginning the trial, and after 12 and 24 weeks of supplementation. They will have a monthly follow-up visit for evaluation of adherence and adverse effects, as well as delivery of the supplement.
Subjects will be randomly allocated to a supplementation with 1000 mg vitamin C, 400 IU vitamin D and 10 mg of zinc or placebo group, during 24 weeks. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin supplement | Experimental | Effervescent tablets containing Vitamin C, Vitamin D and zinc |
|
| Placebo | Placebo Comparator | Effervescent tablets not containing Vitamin C, Vitamin D and zinc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin Supplement | Dietary Supplement | Subjects will be randomly allocated to a supplementation of vitamin C 1000mg, vitamin D 400 IU and zinc 10 mg or an identical placebo. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycemia from baseline to 12 and 24 weeks | Measured in plasma with a Selectra II automated equipment with Randox reactants, in mg/dL | Baseline, 12 and 24 weeks |
| Change in glycosilated Hemoglobin (Hb1Ac) from baseline to 12 and 24 weeks | Measured in plasma with a Selectra II automated equipment with Randox reactants, in percentage | Baseline, 12 and 24 weeks |
| Change in plasma insulin from baseline to 12 and 24 weeks | Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in uU/mL | Baseline, 12 and 24 weeks |
| Change in Homeostatic Model Assesment for Insulin Resistance (HOMA-IR) from baseline to 12 and 24 weeks | Calculated from: HOMA-IR = (insulin x glucose)/405 | Baseline, 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma cytokines from baseline to 12 and 24 weeks | Tumor Necrosis Factor alfa (TNFα), Interferon gamma (IFN-γ), Interleukins 1 beta, 4, 6 and 10 (IL-1β, IL4, IL-6, IL10) & transforming growth factor beta (TGF-β), measured with Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in pg/mL | Baseline, 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma vitamin C from baseline to 12 and 24 weeks | Measured with a Colorimetric assay, in mg/dL | Baseline, 12 and 24 weeks |
| Changes in plasma vitamin D from baseline to 12 and 24 weeks | Measured with a commercial ELISA kit, ng/mL |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Type | URL | Comment |
|---|---|---|---|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2018 | Nov 7, 2018 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 5, 2018 | Nov 7, 2018 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Subjects will be randomly allocated to two groups (vitamin supplement or placebo), with a duration of 24 weeks. Dietary and compliance monthly follow-up and baseline, 12 and 24-week measurements.
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Vitamin Supplement and placebo will be packaged by others not including the investigators, code will be kept secret until the end of the trial or unless a secondary effect is registered and merits the opening of the code
|
| Placebo | Other | Subjects will be randomly allocated to a supplementation of an identical placebo. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding |
|
| Change in plasma adipokines from baseline to 12 and 24 weeks | Adiponectin, resistin and leptin, measured with Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in pg/mL | Baseline, 12 and 24 weeks |
| Change in additional plasma inflammatory markers from baseline to 12 and 24 weeks | Apolipoproteins A and B, C-reactive protein, vascular cell adhesion protein (V-CAM), intercellular adhesion molecule (I-CAM), complement proteins C-3 and C-4, measured with Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in pg/mL | Baseline, 12 and 24 weeks |
| Change in lipid profile from baseline to 12 and 24 weeks | Total cholesterol, HDL-, LDL-, Very Low Density Lipoprotein (VLDL)-cholesterol and triacylglycerides, measured in plasma with a Selectra II automated equipment with Randox reactants, in mg/dL | Baseline, 12 and 24 weeks |
| Changes in markers of oxidative stress from baseline to 12 and 24 weeks | Malondialdehyde (QuantiChromTM), Thiobarbituric acid reactive substances (TBARS Assay Kit), carbonylated proteins (colorimetric), antioxidant capacity (QuantiChromTM Antioxidant Assay Kit), catalase (EnzyChromTM Catalase Assay Kit), superoxide dismutase (EnzyChromTM Superoxide Dismutase Assay Kit) and glutathion peroxidase (metaphosphoric acid SIGMA ALDRICH y EnzyChromTM GSH/GSSG Assay Kit, measured with various commercial kits, in U/μL | Baseline, 12 and 24 weeks |
| Changes in lymphocyte subpopulations from baseline to 12 and 24 weeks | Cluster of desgination 4, 8, 17 and 19 (CD4+, CD8+, CD17+ and CD19+), measured by flow cytometry (Becton Dickinson Facs AriaMR de 6 canales), in percentage | Baseline, 12 and 24 weeks |
| Changes in Intestinal microbiota patterns from baseline to 12 and 24 weeks | Analyzed with a Illumina sequencing equipment and Mothur y Stamp softwares, in percentage | Baseline, 12 and 24 weeks |
| Baseline, 12 and 24 weeks |
| Changes in plasma zinc from baseline to 12 and 24 weeks | Measured with a Colorimetric assay, in mg/dL | Baseline, 12 and 24 weeks |
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| D004700 | Endocrine System Diseases |