Pilot study on the Effects of the GOLO Weight Management Program and RELEASE Supplement on Weight and Glycemic Control in Patients with Type 2 Diabetes Mellitus and Obesity

Abstract

Objective: This pilot studied assessed the effects of the GOLO Weight Management Program with Release supplement on weight and glycemic control in subjects with type 2 diabetes mellitus and obesity. Methods: 26 subjects with type 2 diabetes mellitus and obesity were recruited into an open-label study of the GOLO Weight Management System with Release supplement at a single clinical site. 16 subjects completed the study over a 13-week treatment period. Results: After 13 weeks of open-label treatment, subjects lost an average of -3.3 kg (SD 2.47; p<0.001) which represented an average of -3.53% (SD 0.02) weight loss and was statistically significant. Statistically significant reductions in several body measurement parameters were demonstrated including BMI -1.17 kg/m2 (0.75, p<0.001), waist circumference -6.41 cm (4.22; p<0.001), hip circumference -3.81 cm (3.68, p<0.001), and body fat mass -2.34 kg (2.29, p<0.001). Reductions in Hemoglobin A1C averaged -0.61% (0.86; p=0.01) and reductions in HOMA-IR, a measure of insulin resistance, averaged -2.25 (3.33; p=0.02) both statistically significant. Positive trends were observed in reductions of fasting blood glucose [-24.19 mg/dl (52.31), p=0.08] and insulin levels [-2.91 uIU/dl (5.75); p=0.06] that were not statically significant. Conclusions: Treatment with the GOLO Weight Management Program and Release supplement for 13 weeks resulted in weight loss and improvements in glycemic control and insulin resistance in patients with type 2 diabetes mellitus and obesity. *Correspondence to: Robert J Buynak, MD, 55 University Suite 106, Valparaiso, IN 46385, USA, Tel: 219-464-8302, E-mail: rbuynak@att.net