Phytodiab® in subjects with metabolic syndrome and early type 2 diabetes: a 12-week observational registry study

Type 2 diabetes associated with increased weight is a common metabolic condition that may progress to chronic disease. This pilot observational registry evaluated the effects of Phytodiab^®, a multi-component natural extract formulation, on metabolic and oxidative parameters in subjects with mild-to-moderate type 2 diabetes managed with diet and lifestyle measures.

Sixty adults with type 2 diabetes, moderately overweight, without diabetic complications and not receiving pharmacological treatment, were included. Subjects followed standard lifestyle management (SM) alone (N.=30) or Phytodiab^® plus SM once daily before the main meal (N.=30) for 12 weeks. Outcomes included body weight, fat mass, fasting glucose, glycated hemoglobin (HbA1c), and plasma oxidative stress measured in Carr units. Safety, tolerability, compliance, and routine blood parameters were monitored.

The two groups were comparable at baseline for age, sex distribution, and clinical profile. There were no dropouts and no tolerability problems. Compliance was high, with 96% of tablets correctly used. At 12 weeks, subjects receiving Phytodiab^® showed significant reductions in weight, fat mass, fasting glucose, HbA1c, and oxidative stress compared with controls (P<0.05). Routine laboratory parameters, including kidney and liver function, blood count, coagulation, and platelet activity, remained normal and unchanged.

In this 12-week observational registry, Phytodiab^® plus SM was well tolerated and associated with improvements in metabolic and oxidative parameters in otherwise healthy subjects with mild-to-moderate type 2 diabetes managed with lifestyle measures. These findings are exploratory and support further controlled evaluations in larger populations.