Sponsor study identifier
interventional
22
1 country
1
Study Start
April 26, 2017
Actual (reported)Primary Completion
June 21, 2017
Actual (reported)Study Completion
June 21, 2017
Actual (reported)Blood sugar levels are controlled by insulin, a hormone made by cells in the pancreas. After a meal, carbohydrates are broken down into glucose (blood sugar) which is absorbed from the intestine into the blood leading to a rise in glucose which triggers the secretion of insulin. Insulin binds to cells in the liver, muscle and fat, triggering them to take up glucose and bring the blood glucose level back to normal. A high blood sugar level is known as diabetes. The most common form of diabetes, type 2 diabetes, is caused by insulin resistance; that is, a reduced ability of insulin to stimulate glucose uptake into cells. The body compensates for insulin resistance by making more insulin; type 2 diabetes occurs when the pancreas can no longer make enough insulin to control blood glucose. The high blood glucose and insulin levels lead to long-term complications such as heart attacks, kidney failure, reduced sensation and poor circulation in the feet and legs. Reducing blood glucose levels with oral medications and insulin reduces risk of diabetic complications. There are several types of oral medications available for treating diabetes; however, they do not always control blood glucose adequately. In addition, these drugs have complications and are not used to treat insulin resistance and prediabetes - a condition when blood glucose is higher than normal but not high enough to be classified as diabetes. Prediabetes often progresses to diabetes over a period of months or years. Effective and safe treatments for prediabetes could prevent or delay the onset of diabetes. Axulin is a natural health product consisting of a mixture of extracts - derived from herbs and vegetables present in normal diets - which has been shown in cell culture and in animal studies to increase the ability of insulin to stimulate glucose uptake into cells. The active ingredient in Axulin is a botanical extract designated HP-211. Thus, HP-211 may reduce the blood glucose and insulin levels of subjects without diabetes after eating. HP-211 may also reduce glucose and insulin responses to a larger extent in insulin-resistant as compared to insulin-sensitive subjects. Subjects will take 0g, 2g, or 4g of capsules or tablets in the morning after an overnight fast; 40 minutes later they will consume 75g glucose dissolved in 300ml water. Blood glucose, insulin and fats will be measured before and for 2 hours after the glucose drink.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 21, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 26, 2017
Actual (reported)April 26, 2017
Actual (reported)May 1, 2017
Actual (reported)June 21, 2017
Actual (reported)June 21, 2017
Actual (reported)April 20, 2020
Actual (reported)Percentage Change in Area Under The Curve (AUC) for Blood Glucose 0-2 Hours
Percentage change in the incremental area under the glucose response curve (AUC) after 75g glucose for capsules and tablets containing Axulin powder relative to the water control. Incremental AUC is the AUC below the curve above the fasting level; area below fasting is ignored. Percentage change will be calculated as 100 x (A-P)/P where A and P are the mean AUC's after Axulin and water control treatments, respectively. The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons. The code will be broken after this analysis has been done. The percentage changes will be considered to be significant if the difference in mean AUC is significant.
0, 15, 30, 45, 60, 90, and 120 minutes post-dose
Blood Glucose Area Under The Curve (AUC) 0-2 Hours
0, 15, 30, 45, 60, 90, and 120 minutes post-dose
Serum Insulin Area Under The Curve (AUC) 0-2 Hours
0, 15, 30, 45, 60, 90, and 120 minutes post-dose
Percentage Change in Area Under The Curve (AUC) for Serum Insulin 0-2 Hours
0, 15, 30, 45, 60, 90, and 120 minutes post-dose
Insulinogenic Index
Baseline and 30 minutes
Matsuda Insulin Sensitivity Index
0, 30, 60, 90, and 120 minutes post-dose
Effect of Axulin in Lean vs. Overweight Participants
0, 15, 30, 45, 60, 90, and 120 minutes post-dose
Effect of Capsules vs. Tablets
0, 15, 30, 45, 60, 90, and 120 minutes post-dose
Participants with BMI \>18.5 and \<25.0kg/m²
Participants with BMI ≥25.0 and \<35.0kg/m²
250ml water with 16 x 250mg placebo capsules
250ml water with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules
Glycemic Index Laboratories, Inc.
Toronto, Ontario, M5C 2N8, Canada
Note: The dissolution time for the tablets is substantially longer (\>60 min) than it is for the capsules, so it would not be expected that the tablet formulation would exhibit a pharmacologic response if administered only 40 minutes before the GTT.
Thomas MS Wolever, MD, PhD
Glycemic Index Laboratories, Inc
22 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2017
First Posted
May 1, 2017
Study Start
250ml water with 16 x 250mg capsules containing Axulin powder
250ml water
250ml water with 2 x 1g tablets containing Axulin powder
250ml water with 4 x 1g tablets containing Axulin powder
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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April 26, 2017
Primary Completion
June 21, 2017
Actual (reported)Study Completion
June 21, 2017
Actual (reported)Last Updated
April 20, 2020
Results First Posted
April 20, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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