INS and diabetes mellitus: 12 months: Weight loss (-3.89% vs. -1.27%, P < 0.001), HbA1c reduction (-0.62% vs. 0.27%, P < 0.002) vs. placebo.- Lowers fasting glucose, insulin levels, and antidiabetic drug doses.- No documented diabetes remission rates (HbA1c < 6.5% without antihyperglycemic medications).