The Effectiveness of Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy: A Randomized, Controlled Clinical Trial

摘要

Aims/Introduction: Effectiveness of Diamel? on the biochemical variables: fasting blood glucose, postprandial glucose, cholesterol, triglycerides, and glycosylated haemoglobin [HbA1c] in type-2 diabetic patients receiving insulin terapy. Diamel is a natural product composed of trace elements: amino acids, vitamins, cranberry extract, and lettuce extract that have been activated by means of a magnetization process. Materials and methods: Randomized, doubleblind, comparator-controlled clinical trial. A central randomization centre used computer generated tables to allocate treatments. 116 patients suffering from type-2 diabetes mellitus treated with insulin at the Diabetes Care Centre in Pinar del Rio (Cuba), were recruited and randomly. The subjects were separated into two groups: Group A (n = 59), who were administered Diamel and Group B (n = 57) using placebo. The clinical and biochemical variables were assessed for 24 weeks. Results: Two subjects were excluded from the Diamel treatment group during the clinical trial. From the statistical point of view, a significant drop in the levels of the baseline glucose, postprandial glucose, glycated haemoglobin, and triglycerides was observed in the group taking Diamel (Group A). There was observed an increase in insulin requirements and in waist circumference in the subjects of Group B There was not reported any severe or serious adverse reactions during this clinical trial. Conclusion: Diamel (nutritional supplement) together with the administration of insulin in type-2 diabetic patients is useful to optimize the biochemical variables (baseline and postprandial glucose, Hb A1C, plus triglycerides), as well as to prevent the increase of insulin requirements at medium-term.