Effect of a dietary fiber and magnesium supplement on endothelial dysfunction, inflammation and glycemic control markers in patients with type 2 diabetes mellitus. Randomized, double-blind clinical trial.

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
INTERVENTION: There are four arms of treatment. All four groups received the best therapy available to control dm2 which include the ADA nutrition treatment guidelines. There was a nutritionist that gave specific suggestions according to each patient's needs, with an indication of losing weight if necessary. All patients received oral hypoglycaemic products and antihypertensive therapy as much as was needed to achieve the target levels of glucose and blood pressure. Patients were randomised to receive one of the following interventions: 1. Active cookies and active tablets 2. Combination of placebo and active cookies 3. Combination of placebo and active tablets 4. Control group: placebo cookies and placebo tablets CONDITION: Diabetes mellitus type 2 ; Nutritional, Metabolic, Endocrine ; Diabetes PRIMARY OUTCOME: Biomarkers of endothelial dysfunction (selectin 2, vascular cell adhesion molecules [vcam]) and intercellular adhesion molecule [icam]) SECONDARY OUTCOME: 1. Serum levels of inflammation markers (interleukin‐6, C‐reactive protein); 2. Plasma levels of glycemic control markers (glycated hemoglobin and glucose) INCLUSION CRITERIA: 1. Having diabetes mellitus type 2 (dm2) according to the American Diabetes Association (ADA) criteria 2. Male or female 3. Up to 48 months of dm2 diagnosis 4. Aged 30‐70 years
Epistemonikos ID: 2c0a8fbeec50a4e0ca4c499d752b2b7750320403
First added on: Aug 21, 2024