Background

The main objective of this study is to evaluate the efficacy of dTMS in the control of food craving and in the reduction of body weight in diabetic and obese subjects. The effect of dTMS on metabolic parameters related to glucose metabolism (glycated hemoglobin and fructosamine) is also evaluated.

Methods

A total of 36 obese patients (10 males, 26 females, age 48.4±9.9 yrs, BMI 36.4±4.4 Kg/m2) were randomised and completed the study: 7 obese diabetic (DO) and 15 non-diabetic obese (NDO) subjects underwent a 5-week treatment with high-frequency (HF, 18 Hz) dTMS and 4 DO and 10 NDO subjects were Sham-treated. Food craving and metabolic parameters were evaluated at baseline, after the 5-week treatment, and at follow-up visits (1 month, FU1, 6 months, FU2, 1 year, FU3, after the end of the treatment).

Results

The weight reduction was significantly higher in the DO18Hz group than in DOsham (respectively -3.9±1.2% and -1.4±1.3%; p=0.022).A significant reduction in glycated hemoglobin was observed in DO18Hz group: after the 5-weeks treatment (-8.4±3.0% vs baseline, p=0.015) and at FU1 (-9.0±2.8% vs baseline, p=0.010).A significant reduction in fructosamine was observed in DO18Hz group at FU1 (-7.5±4.3% vs baseline, p=0.009).

Conclusions

We demonstrated the effectiveness of HF dTMS in the reduction of body weight and in the improvement of metabolic and hormonal parameters related to glucose metabolism in type 2 diabetes, with long-lasting effects.The present results constitute proof of principle to consider dTMS a useful tool in the management of type 2 diabetes mellitus associated with obesity.