Abnormalities of retinal ganglion cell complex at optical coherence tomography in patients with type 2 diabetes: a sign of diabetic polyneuropathy, not retinopathy.

AIMS: To compare optical coherence tomography (OCT)-derived neuro-retinal parameters in patients with type 2 diabetes and non-diabetic controls and to evaluate their correlation with diabetic retinopathy (DR) and polyneuropathy (DPN). METHODS: One-hundred consecutive patients with type 2 diabetes were examined by spectral-domain (SD) OCT for evaluating ganglion cell complex (GCC) and retinal nerve fibre layer (RNFL) thickness and two new pattern-based quantitative measures of GCC damage, global and focal loss volume (GLV and FLV). Fifty sex- and age-matched non-diabetic subjects served as control. RESULTS: RNFL thickness (101.0±10.6 vs. 106.4±10.3 µm, P=0.003) was significantly lower and GLV (6.58±4.98 vs. 4.52±3.10 %, P=0.008) and FLV (1.90±1.97 vs. 0.89±0.84 %, P<0.0001) were significantly higher in diabetic versus control subjects. The OCT parameters did not differ significantly according to DR grade. Conversely, RNFL thickness was lower and GLV and FLV were higher in patients with versus those without DPN, and the extent of changes increased significantly with quartiles of DPN score. At both bivariate and multivariate analysis, OCT parameters, especially FLV, correlated significantly with DPN measures. CONCLUSIONS: The GCC is significantly affected in patients with type 2 diabetes and SD-OCT might represent a useful tool to detect DPN, but not DR in these individuals.

The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle.

BACKGROUND: Physical activity (PA)/exercise have become an integral part of the management of type 2 diabetes mellitus (T2DM). However, current guidelines are difficult to put into action in this population due to a number of barriers, especially the lack of acceptable, feasible, and validated behavioral intervention strategies. The present manuscript reports the rationale, study design and methods, and design considerations of the Italian Diabetes and Exercise Study (IDES)-2, a randomized controlled trial testing the efficacy of a behavior change strategy in increasing total daily PA and reducing sedentary time (SED-time) in patients with T2DM. METHODS/DESIGN: Starting 7 January 2014, the IDES_2 began enrolling 300 patients with known T2DM of at least 1-year duration in three tertiary referral outpatient Diabetes Clinics in Rome. Additional requirements are age 40 to 80 years, body mass index 27 to 40 kg/m(2), sedentary lifestyle, and physically inactive for at least 6 months, ability to walk 1.6 km without assistance, and eligibility after cardiovascular evaluation. Patients are randomized by center and within each center, by age and type of diabetes treatment to either the intervention or the control group. Patients in the intervention (INT) group (n = 150) receive theoretical and practical exercise counseling consisting of aggregated behavior change techniques (one individual theoretical counseling session plus eight twice-a-week individual theoretical and practical exercise counseling sessions) once a year for 3 years. Patients in the control (CON) group (n = 150), receive standard care, including general physician recommendations for daily PA. The primary outcomes are total daily PA and SED-time, as measured objectively by the use of an accelerometer. Secondary outcomes include physical fitness, modifiable cardiovascular risk factors, musculoskeletal disturbances, well-being/depression, and health-related quality of life. DISCUSSION: The behavioral intervention strategy tested in the IDES_2 is based on solid theoretical grounds and uses several behavioral change techniques, two factors which were found to improve effectiveness of behavioral intervention. In addition, physicians and exercise specialists have been specifically trained for counselling/prescribing and supervising PA/exercise, respectively, in subjects suffering from metabolic disorders. Finally, the large sample size, the long study duration, and the objective measurement of PA allow statistically significant and scientifically robust conclusions to be drawn on the feasibility and efficacy of this intervention in T2DM patients. TRIAL REGISTRATION: ClinicalTrials.gov; NCT01600937 ; 10 October 2012.

Volume-dependent effect of supervised exercise training on fatty liver and visceral adiposity index in subjects with type 2 diabetes The Italian Diabetes Exercise Study (IDES).

AIMS: This study evaluated the effect of supervised exercise training on liver enzymes and two surrogate measures of non-alcoholic fatty liver disease (NAFLD) in subjects with type 2 diabetes. METHODS: Sedentary patients from 22 outpatient diabetes clinics were randomized by center, age and treatment to twice-a-week supervised aerobic and resistance training plus structured exercise counseling (exercise group, EXE; n=303) versus counseling alone (control group, CON; n=303) for 12 months. EXE participants were further randomized to low-to-moderate (n=142) or moderate-to-high (n=161) intensity training of equal energy cost. Baseline and end-of-study levels of liver enzymes, fatty liver index (FLI) and visceral adiposity index (VAI) were obtained. RESULTS: Enzyme levels did not change, whereas FLI and VAI decreased significantly in EXE, but not CON participants. Physical activity (PA) volume was an independent predictor of both FLI and VAI reductions, the extent of which increased from the 1st to the 4th quintile of PA volume and baseline to end-of-study changes in fitness parameters. Differences in the effect of LI versus HI training were negligible. CONCLUSIONS: Data from this large cohort of subjects with type 2 diabetes indicate that FLI and VAI decrease with supervised training in a volume-dependent manner.

Effect of high- versus low-intensity supervised aerobic and resistance training on modifiable cardiovascular risk factors in type 2 diabetes; the Italian Diabetes and Exercise Study (IDES).

BACKGROUND: While current recommendations on exercise type and volume have strong experimental bases, there is no clear evidence from large-sized studies indicating whether increasing training intensity provides additional benefits to subjects with type 2 diabetes. OBJECTIVE: To compare the effects of moderate-to-high intensity (HI) versus low-to-moderate intensity (LI) training of equal energy cost, i.e. exercise volume, on modifiable cardiovascular risk factors. DESIGN: Pre-specified sub-analysis of the Italian Diabetes and Exercise Study (IDES), a randomized multicenter prospective trial comparing a supervised exercise intervention with standard care for 12 months (2005-2006). SETTING: Twenty-two outpatient diabetes clinics across Italy. PATIENTS: Sedentary patients with type 2 diabetes assigned to twice-a-week supervised progressive aerobic and resistance training plus exercise counseling (n = 303). INTERVENTIONS: Subjects were randomized by center to LI (n = 142, 136 completed) or HI (n = 161, 152 completed) progressive aerobic and resistance training, i.e. at 55% or 70% of predicted maximal oxygen consumption and at 60% or 80% of predicted 1-Repetition Maximum, respectively, of equal volume. MAIN OUTCOME MEASURE(S): Hemoglobin (Hb) A(1c) and other cardiovascular risk factors; 10-year coronary heart disease (CHD) risk scores. RESULTS: Volume of physical activity, both supervised and non-supervised, was similar in LI and HI participants. Compared with LI training, HI training produced only clinically marginal, though statistically significant, improvements in HbA(1c) (mean difference -0.17% [95% confidence interval -0.44,0.10], P = 0.03), triglycerides (-0.12 mmol/l [-0.34,0.10], P = 0.02) and total cholesterol (-0.24 mmol/l [-0.46, -0.01], P = 0.04), but not in other risk factors and CHD risk scores. However, intensity was not an independent predictor of reduction of any of these parameters. Adverse event rate was similar in HI and LI subjects. CONCLUSIONS: Data from the large IDES cohort indicate that, in low-fitness individuals such as sedentary subjects with type 2 diabetes, increasing exercise intensity is not harmful, but does not provide additional benefits on cardiovascular risk factors. TRIAL REGISTRATION: www.ISRCTN.org ISRCTN-04252749.