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Mild electrical stimulation with heat shock reduces visceral adiposity and improves metabolic abnormalities in subjects with metabolic syndrome or type 2 diabetes: randomized crossover trials [with consumer summary]
Kondo T, Ono K, Kitano S, Matsuyama R, Goto R, Suico MA, Kawasaki S, Igata M, Kawashima J, Motoshima H, Matsumura T, Kai H, Araki E
EBioMedicine 2014 Nov 11;1(1):80-89
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The induction of heat shock protein (HSP) 72 by mild electrical stimulation with heat shock (MES plus HS), which improves visceral adiposity and insulin resistance in mice, may be beneficial in treating metabolic syndrome (MS) or type 2 diabetes mellitus (T2DM). METHODS: Using open-label crossover trials, 40 subjects with MS or T2DM were randomly assigned using computer-generated random numbers to 12 weeks of therapeutic MES plus HS followed by 12 weeks of no treatment, or vice versa. During the intervention period, physical and biochemicalmarkers weremeasured. FINDINGS: Compared to no treatment, MES plus HS treatment was associated with a significant decrease in visceral adiposity (-7.54 cm2 (-8.61%), 95% CI -8.55 to -6.53 (p = 0.037) in MS, -19.73 cm2 (-10.89%), 95% CI -20.97 to -18.49 (p = 0.003) in T2DM). Fasting plasma glucose levels were decreased by 3.74 mg/dL (-5.28%: 95% CI -4.37 to -3.09 mg/dL, p = 0.029) in MS and by 14.97 mg/dL (10.40%: 95% CI -15.79 to 14.15 mg/dL, p > 0.001) in T2DM, and insulin levels were also reduced by 10.39% and 25.93%, respectively. HbA1c levels showed a trend toward reduction (-0.06%) in MS, and was significantly declined by -0.43% (95% CI -0.55 to -0.31%, p = 0.009) in T2DM. HbA1c level of less than 7.0% was achieved in 52.5% of the MES plus HS-treated T2DM patients in contrast to 15% of the non-treated period. Several insulin resistance indices, inflammatory cytokines or adipokines, including C-reactive protein, adiponectin, and tumor necrosis factor-a, were all improved in both groups. In isolated monocytes, HSP72 expression was increased and cytokine expression was reduced following MES plus HS treatment. Glucose excursions on meal tolerance test were lower after using MES plus HS in T2DM. INTERPRETATION: This combination therapy has beneficial impacts on body composition, metabolic abnormalities, and inflammation in subjects with MS or T2DM. Activation of the heat shock response by MES plus HS may provide a novel approach for the treatment of lifestyle-related diseases.

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