A Randomized, placebo controlled study to assess the efficacy & safety of nutritional and phytoconstituents supplementation in prediabetic subjects

Prediabetes is the earliest identifiable stage of glucose dysregulation, characterized by plasma glucose levels that are intermediate between normal glucose tolerance and diabetes. In prediabetes there is a disrupted fat metabolism and early stage of disrupted insulin regulation i.e., reduced insulin sensitivity. Obesity is the most powerful yet modifiable risk factor for diabetes.  It is linked with an increased insulin demand and increased likelihood of insulin resistance leading to prediabetes or hyperinsulinemia and then ultimately T2DM. 

Nutritionalintervention is important for preventing diabetes, managing existing diabetes& preventing or at least slowing, the rate of development of diabetes complications.Dietary factors are of paramount importance in the management & prevention prediabetes.Balancing the right amount of macronutrients & micronutrients helps us tomaintain a healthy diet & a healthy lifestyle.

Micronutrientsserve dual roles: they maintain the stabilization of the cellular structures attheir optimal levels, but their inadequacy proceeds to alternate pathways andmay cause ailments. These essential micronutrients have important physiologicalimplications and exhibit direct associations with diabetes mellitus.

Micronutrientsare identified as vital nutrients that are required in trace amounts forhomeostasis, enzyme regulation and functioning. Macro elements, vitamins, traceelements and organic acids are the four major classes of micronutrients. Theyenhance insulin action by activating insulin receptor sites. These traceelements play specific roles in the pathogenesis and progression of type 2diabetes mellitus (T2DM) and the mode of action of a number of macro and traceelements is altered in T2DM.

Apersonalized approach for preventing and managing prediabetes should considerbiological and behavioral models, and embed nutrition education as part oflifestyle diabetes prevention studies. Functional foods may provide additionalbenefits in such an approach.

Phytoconstituents in cinnamon such as cinnamomum aromaticum (Cassia), cinnamomumzeylanicum, etc. have been demonstrated its effect in managingdiabetes and metabolic disorder by upregulating glucose uptake, increasingglycogen synthesis, inhibiting glycogen breakdown, and reducing glucoseabsorption in the small gut. Phytoconstituents in fenugreek namely, diosgenin,4-hydroxyisoleucine, alkaloid and the fiber component, are the most studiedbioactive fractions of the plant, which were found to exert beneficial effectson lowering blood glucose, glucose tolerance, insulin function, inflammatoryresponse, lipid profile, and liver functions.

Diabetone tablets are blend of micronutrients andcinafen plus possess standardized extracts of cinnamon and fenugreek. Thepresent research is an attempt to assess the efficacy & safety of Diabetone and Cinafen plus tablets insubjects with prediabetes. With the present research we can apply theknowledge of pharmacological benefits of micronutrients along with the clinicaltrials to address the important medical issue of growing prediabetic populationto improve glycaemic control, control the disease progression and possibly toreverse the condition. To provide appropriate and timely care to prediabeticsubjects, achieve good control of glycemia, reduce the risk of complicationsrelated to diabetes, minimise healthcare use, and associated costs by reversingthe devastating condition and thereby improving the subjects’ quality of life,it is necessary to begin primary translational work as soon as possible.

Asper the macronutrient recommendations for remission and prevention of Diabetesin Asian Indians, with adjusting the proper balance of carbohydrates, proteinand fats in diet the remission, and prevention of progression to T2DM isobserved.  In line with this study our hypothesis is in longer perspective,micronutrients and phytoconstituents based supplementation will provide goodprognosis to the disease with less or no dependency on conventionalantidiabetic medication together with reduced or no side effects. Moreover,improved glycemic control will avoid acute decompensation, delay or preventionof microvascular (retinopathy, nephropathy, and neuropathy) and macrovascularcomplications, reduce mortality, and maintain a good quality of life. Asystematic clinical validation of the investigational products in comparisonwith placebo from the present study will provide a guideline and evidence forcare givers and diabetologists to use the standardized nutrition andphytoconstituents in their clinical practice in the management of prediabetes.