Insulin Resistance, Diabetes Clinical Trial
Official title:
Acute Effect of HP-211 (Axulin) on Blood Glucose and Serum Insulin Responses in Healthy Lean and Overweight Humans
Verified date | January 2020 |
Source | Housey Healthcare ULC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | June 21, 2017 |
Est. primary completion date | June 21, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Participants taking stable doses (for at least 4 weeks of signing the consent form) of the birth control pill, thyroxin replacement therapy, statins, fibrates, cholesterol absorption inhibitors, anti-hypertensive medications, asprin, non-steroidal anti-inflammatories and/or mild anxiolytics or sedatives can be included. Exclusion Criteria: - Fasting serum glucose >6.9mmol/L (124mg/dL) - HbA1c >6.4% - Fasting serum triglycerides >4.5 mmol/L (399 mg/dL) - Fasting LDL cholesterol >4.99 mmol/L (192 mg/dL) - Blood pressure >149 systolic or >89 diastolic - Serum creatinine, or aspartate- or alanine transaminases >1.2 times upper limit of normal - White cell count, red blood cell count, hemoglobin or hematocrit outside normal range - Hospitalization for surgery or a medical condition within 3 months of signing the consent form - Use of any drug to treat diabetes - Use of medications other than those listed above or the presence of any condition which might, in the opinion of Dr. Wolever, either: 1) make participation dangerous to the subject or to others, or 2) affect the results - Allergy or sensitivity to tarragon, chromium, escarole, lettuce, microcrystalline cellulose, inulin, food colouring (FD&C Yellow#5 and Blue#1) or vegetable-based capsules (silicon dioxide, titanium dioxide, hydroxypropylmethylcellulose) |
Country | Name | City | State |
---|---|---|---|
Canada | Glycemic Index Laboratories, Inc. | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Housey Healthcare ULC | Glycemic Index Laboratories, Inc |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Effect of Axulin in Lean vs. Overweight Participants | Percentage change in blood glucose area under the curve (AUC) in lean participants compared to overweight participants. | 0, 15, 30, 45, 60, 90, and 120 minutes post-dose | |
Other | Effect of Capsules vs. Tablets | Percentage change in blood glucose area under the curve (AUC) elicited by capsules compared to the same dose of tablets. | 0, 15, 30, 45, 60, 90, and 120 minutes post-dose | |
Primary | 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 | |
Secondary | Blood Glucose Area Under The Curve (AUC) 0-2 Hours | Incremental area under the blood glucose response curve (AUC) is the AUC below the glucose response curve above the fasting level; area below fasting is ignored. 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. | 0, 15, 30, 45, 60, 90, and 120 minutes post-dose | |
Secondary | Serum Insulin Area Under The Curve (AUC) 0-2 Hours | Incremental area under the serum insulin response curve (AUC) is the AUC below the insulin response curve above the fasting level; area below fasting is ignored. 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. | 0, 15, 30, 45, 60, 90, and 120 minutes post-dose | |
Secondary | Percentage Change in Area Under The Curve (AUC) for Serum Insulin 0-2 Hours | Percentage change in the incremental area under the insulin response curve (AUC) after 75g glucose for the capsules 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 | |
Secondary | Insulinogenic Index | Insulinogenic Index is an index of the ability of a change in blood glucose to stimulate an increase in serum insulin. It is a unitless measure with higher numbers indicating improved beta cell function. It is calculated by dividing the change in serum insulin between 0 and 30 minutes by the change in blood glucose between 0 and 30 minutes. | Baseline and 30 minutes | |
Secondary | Matsuda Insulin Sensitivity Index | Matsuda Insulin Sensitivity Index is an index of whole body insulin sensitivity derived from glucose and insulin responses after a 75g Oral Glucose Tolerance Test (OGTT). It is calculated by 10000 divided by the square root of (FG*FI*MG*MI) where FG is fasting glucose, FI is fasting insulin, MG is the mean AUC for blood glucose at 0, 30, 60, 90 and 120 minutes and MI is the mean AUC for serum insulin at 0, 30, 60, 90 and 120 minutes. | 0, 30, 60, 90, and 120 minutes post-dose | |
Secondary | ISSI-2 Index of Beta-cell Function | Insulin Secretion-Sensitivity Index-2 (ISSI-2) is an index of ß-cell function with insulin secretion adjusted for whole body insulin sensitivity. It is calculated by the total area under the curve for serum insulin divided by the area under the curve for blood glucose, and that result times the Matsuda insulin sensitivity index (defined above). | 0, 30, 60, 90, and 120 minutes post-dose |
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