Phase 1
N=22
Acute Effect of HP-211 (Axulin) on Blood Glucose and Serum Insulin Responses in Healthy Lean and Overweight Humans
Insulin Resistance, Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03135015 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Percentage Change in Area Under The Curve (AUC) for Blood Glucose 0-2 Hours — 301.09; 258.66; 248.63; 274.13 mmol x min/L — p=0.1146
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo capsules (Other); 2g capsules (Other); 4g capsules (Other); Water Control (Other); 2g tablets (Other); 4g tablets (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Housey Healthcare ULC
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Area Under The Curve (AUC) for Blood Glucose 0-2 Hours |
301.09; 258.66; 248.63; 274.13; 325.73; 306.19 | 0.1146 |
| SECONDARY Blood Glucose Area Under The Curve (AUC) 0-2 Hours |
301.09; 258.66; 248.63; 274.13; 325.73; 306.19 | 0.1146 |
| SECONDARY Serum Insulin Area Under The Curve (AUC) 0-2 Hours |
4379.31; 4005.61; 4787.44; 4135.18; 4452.09; 4381.71 | 0.5827 |
| SECONDARY Percentage Change in Area Under The Curve (AUC) for Serum Insulin 0-2 Hours |
4379.31; 4005.61; 4787.44; 4135.18; 4452.09; 4381.71 | 0.5827 |
| SECONDARY Insulinogenic Index |
11.462; 15.540; 17.436; 15.059; 13.785; 13.580 | 0.1234 |
| SECONDARY Matsuda Insulin Sensitivity Index |
206.116; 165.289; 155.64; 186.468; 167.004; 189.457 | <0.0500 sig |
| SECONDARY ISSI-2 Index of Beta-cell Function |
816.475; 705.232; 773.354; 727.130; 783.328; 880.822 | 0.0509 |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03135015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.