A single blinded, randomized, intention-to treat, parallel group intervention study was performed over 12 months to examine the effect of a lifestyle intervention program in subjects with impaired glucose tolerance (IGT) or type 2 diabetes mellitus (T2DM) and neuropathy.

Currently there are no effective disease modifying treatments for diabetic neuropathy (DN).  A lifestyle intervention can reduce the incidence of type 2 diabetes and in T2DM subjects without DN, can ameliorate the development of DN.  Uncontrolled trials with short term lifestyle changes may affect some of the symptoms of DN.  However, data from randomized control trials is lacking.

The lifestyle intervention program consisted of a dietary weight loss intervention that was tailored to the participants’ caloric expenditure and a graded, increasing, moderate intensity aerobic physical activity intervention that was tailored to the participants’ baseline physical activity (TDPA). The TDPA intervention group was compared to a standard care (SC) group receiving general dietary and exercise advice.  The primary caregivers, those measuring endpoints, and the statistician were masked to the trial intervention.  Masking to the trial intervention was achieved in 81% of participants. The primary efficacy measure was improvement in the 6 minute walk test (6MW) and the secondary efficacy measure was improvement in the intraepidermal nerve fiber density (IENFD).

72 subjects were randomized into the study with equal numbers completing the study in each group.  At 6 months, there was an increase in the 6MW >25 meters (P=0.02) and >6 meters at 12 months (P=0.03) and an improvement in the thigh IENFD at 12 months (P = 0.04).

In this randomized, blinded, intention-to-treat study of a lifestyle intervention in diabetic neuropathy, there is improvement in mobility and the IENFD in the TDPA compared to SC intervention group.  This offers a potential intervention for diabetic neuropathy.