The role of leptin in human pathophysiology elicits considerable interest in view of its potential role as a treatment tool for obesity and other insulin resistant states, like type 2 diabetes mellitus (T2DM). Leptin has been extensively studied in obese humans, and much less so in other pathologic conditions. Leptin level has been reported to correlate with percent body fat mass (%FM), fasting serum insulin (FPI), insulin sensitivity and blood pressure. The aim of this study was to compare the leptin concentration, and its relationship with some anthropometric and biochemical parameters related to insulin resistance in 140 moderately obese type 2 diabetics (T2DM) and 160 age and weight matched non-diabetic controls in order to get a better insight into the possible role of leptin in the metabolic abnormalities of diabetes. The leptin levels were lower in the diabetic population only when both sexes were combined (p < 0.05) and were higher in the females of both groups. Among the nondiabetics, the leptin levels appeared to be related to BMI, %FM, HDL and FPI, while this was not the case in the diabetics. After correction for BMI, leptin appeared to be correlated with the FPI levels only in the non-diabetic females. When plasma leptin was included in a multiple linear regression model with plasma leptin as a dependent variable, BMI, W:Hr and FPI levels were significantly related to leptin in the non diabetic population, while no relationship reached the level of statistical significance among the diabetics, with the exception of the borderline value for the FPI (p = .052). In conclusion, leptin levels were independent of any of the parameters examined in our diabetic population, possibly due to the progressive loss of the normal mechanisms of leptin regulation with advancing disease. Conclusive data can only be obtained from the longitudinal study of a cohort of newly diagnosed diabetic subjects.

We treated 96 obese diabetic subjects (BMI 33-44 kg/m 2 ) with a "package of interventions" including therapeutic education, regular follow-up at 15-day intervals and a hypocaloric diet of 60% of their daily needs, 20% at breakfast and 40% at each meal. At the beginning of the observation and after 3 and 6 months we checked certain baseline characteristics. All the subjects performed self blood glucose measurement (SMBG) 3 or 5 times a day and kept a log. After the first 3 months of observation (Phase 1) 18 were lost to follow-up and 40 who obtained a weight loss >5% of their initial BW continued on their diet (G-). The remaining 38 substituted a nutritionally rich hypocaloric meal (Glucerna ® SR) for 206 calories of one of the main meals (G+). During the following three months (Phase 2) all were treated with the package of interventions. The subjects treated with Glucerna ® SR had a more consistent weight loss and a more remarkable improvement of the parameters under evaluation, with greater statistical significance. With the logistic regression analysis the residual variance not explained by the weight loss was greater for the G+ group, which implies the existence of an additional beneficial effect of the formula used. Of great relevance is the observation that the G+ group had a reduction of the standard deviation of the SMBG data, thus suggesting a greater stability of the BG values in this group.

Subjects with type 2 diabetes are in a continuous catabolic state due to increased neoglycogensis during most of the fasting and the postprandial period. We compared the body cell mass index (BCMI) of 257 subjects with type 2 diabetes mellitus (T2DM) and 216 non-diabetic controls and found a statistically significant lower value in the diabetic subjects. This abnormality was reversed after 6 months of treatment with a diabetes-specific nutritional formula. Furthermore, in a population of 715 diabetic subjects without other diseases, we found that the BCMI was inversely correlated with the prevailing HbA1c and the duration of the disease.

We treated 96 obese diabetic subjects (BMI 33-44 kg/m 2 ) with a "package of interventions" including therapeutic education, regular follow-up at 15-day intervals and a hypocaloric diet of 60% of their daily needs, 20% at breakfast and 40% at each meal. At the beginning of the observation and after 3 and 6 months we checked certain baseline characteristics. All the subjects performed self blood glucose measurement (SMBG) 3 or 5 times a day and kept a log. After the first 3 months of observation (Phase 1) 18 were lost to follow-up and 40 who obtained a weight loss >5% of their initial BW continued on their diet (G-). The remaining 38 substituted a nutritionally rich hypocaloric meal (Glucerna ® SR) for 206 calories of one of the main meals (G+). During the following three months (Phase 2) all were treated with the package of interventions. The subjects treated with Glucerna ® SR had a more consistent weight loss and a more remarkable improvement of the parameters under evaluation, with greater statistical significance. With the logistic regression analysis the residual variance not explained by the weight loss was greater for the G+ group, which implies the existence of an additional beneficial effect of the formula used. Of great relevance is the observation that the G+ group had a reduction of the standard deviation of the SMBG data, thus suggesting a greater stability of the BG values in this group.

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