Evans M.,KGK Synergize Inc. |
Judy W.V.,SIBR Research Inc. |
Wilson D.,London Health Sciences Center |
Rumberger J.A.,Princeton Longevity Center |
Guthrie N.,KGK Synergize Inc.
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy | Year: 2015
Background: This study investigated the efficacy of Diabetinol® in people with diabetes on medication but not meeting the American Association of Clinical Endocrinologists and American Diabetes Association glycemic, blood pressure, and lipid targets. Subjects and methods: Fifty subjects, aged 18–75 years, with fasting blood glucose ≤15.4 mmol/L, hemoglobin A1c levels ≤12%, and a body mass index between 25 and 40 kg/m2, were enrolled in a 24-week, randomized, double-blind, placebo-controlled, parallel study. Diabetinol® or placebo was administered as 2×525 mg capsules/day. Results: In the Diabetinol® group, 14.3% versus 0% in the placebo group, 33.3% versus 15.4% in placebo, 20.0% versus 12.5% in placebo, and 83.3% versus 60% in placebo achieved the American Association of Clinical Endocrinologists and American Diabetes Association targets for hemoglobin A1c, low-density lipoprotein, total cholesterol, and systolic blood pressure, respectively. There was no difference in the maximum concentration (Cmax) of serum glucose or area under the curve (AUC)0–240 minutes. The time to Cmax was longer for participants on Diabetinol® than placebo group at week 12 (P=0.01). Fasting blood glucose increased from baseline to week 24 in both groups; however, this increase was 14.3 mg/dL lower in the Diabetinol® group versus placebo. The Diabetinol® group showed an increase of 5.53 mg/dL in fasting insulin at week 12 (P=0.09) and 3.2 mg/dL at week 24 (P=0.41) over and above the placebo group. A decrease of 1.5% in total cholesterol, 5.8% in low-density lipoprotein, and a 1.6% increase in high-density lipoprotein concentrations were seen in the Diabetinol® group. Diabetinol® improved 6-month oral glucose tolerance test and 2-hour postprandial glucose profiles in participants between 40 and 60 years of age. Conclusion: The current study suggests a role for Diabetinol® as an adjunctive therapy for glycemic maintenance and for decreasing the risk of diabetes-associated comorbidities in type 2 diabetic patients on conventional therapies. © 2015 Evans et al.
Judy W.,SIBR Research Inc. |
Stogsdill W.,SIBR Research Inc. |
Judy D.,SIBR Research Inc. |
Judy J.,SIBR Research Inc. |
And 3 more authors.
Journal of Functional Foods | Year: 2010
The anwti-diabetic potential of Diabetinol™ was tested in an animal model and in a pilot study in humans. Male Syrian golden hamsters (n= 18) were fed regular chow, 60% fructose or a 60% fructose diet + 1% Diabetinol™. Hamsters fed 60% fructose. + 1% Diabetinol™ demonstrated a decrease in blood glucose, serum insulin, total cholesterol and triacylglycerol levels as compared to the fructose-fed animals. Efficacy of Diabetinol™ (2 × 525. mg/day) was investigated in a randomized, placebo-controlled, double-blind trial where subjects (n= 19) with impaired fasting glucose (IFG) on either Diabetinol™ or placebo were presented with a standard oral glucose challenge. After 84. days of supplementation a significant reduction (p< 0.01) in glucose intolerance, total cholesterol, LDL-cholesterol and decreasing trends in the HbA1c were observed in subjects supplemented with Diabetinol™. This study demonstrated an important future role for the Diabetinol™ in glycemic control and management of risk factors in subjects with IFG on oral medication. © 2010 Elsevier Ltd.