A randomized, open-label, intervention study to evaluate the effect of diet composition on weight gain in obese, type 2 diabetes patients receiving intensive insulin therapy

Purpose. To determine whether obese type 2 diabetes patients starting intensive insulin therapy experience less weight gain and/or maintain body weight by consuming a high-monounsaturated fatty acid (MUFA) diet compared to patients consuming a conventional diabetic (ADA) diet. Secondary objectives in the study were to determine whether the effect of a MUFA diet will lead to: (1) better glycemic control (A1c, FPG), (2) better lipid control (TCHO, HDL, LDL, TG), (3) lower blood pressure levels (SBP, DBP), (4) require less insulin, and (5) experience fewer hypoglycemia events.;Design. This study was a randomized, open-label, intervention study. The sample included 76 male type 2 diabetic patients starting intensive insulin therapy.;Methods. This study examined the effect of diet composition on weight gain. Covariates included age, gender, race, education level, marital status, smoking status, hunger level, satisfaction with the diet, compliance with the diet, and exercise level. The methodology was a 35-week, openlabel, randomized, intervention study conducted in an outpatient diabetes clinic at the Veterans Affairs Southern Nevada Healthcare System in Las Vegas, Nevada. Seventy-six male veterans with type 2 diabetes and a BMI greater than 30 were randomized to a 1600 calorie ADA diet (N = 39) or a 1600 calorie MUFA diet (N = 37). All participants were newly started on intensive insulin therapy. Data analysis used the SPSS software 16.0 version. Descriptive statistics, the independent t-test, relative risk, Pearson's correlation coefficient, Pearson's chi-square and the General Linear Model with repeated measures were utilized to analyze quantitative data.;Findings. T-tests revealed no association (p > .05) between the effects of diet composition on weight gain (p = .90), BMI (p = .80), WHR (p = .38), A1c (p = .36), FPG (p = .80), TCHOL (p = .18), HDL (p = .27), LDL (p = .80), TG (p = .30), SBP (p = .06), DBP (p = .45) and insulin dose (p = .11). Pearson's chi square for independence identified no association (p = .683) between the effects of diet composition on hypoglycemia events.;Conclusions. A MUFA diet can be used as an alternate to the conventional ADA diet when managing obese type 2 diabetes patients treated with intensive insulin therapy. Dietary restriction to 1600 calories in diabetes patients on intensive insulin therapy decreased the A1c value by 1.3 points in the ADA group and 1.5 points in the MUFA group without weight gain and without additional insulin required. In conclusion the total calorie count was more important for preventing weight gain and reducing the A1c in patients on intensive insulin therapy than was dietary composition.