A Clinical Trial to Examine the Efficacy and Safety of an Investigational Product With and Without Use of Semaglutide on Glycemic Response in Adults With Prediabetes or Type 2 Diabetes
Recruiting · London, Ontario
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What is this study?
This is a randomized, single-blind, controlled, parallel clinical trial to examine the efficacy and safety of AMPK Charge+® with and without use of semaglutide on glycemic response in adults with prediabetes or Type 2 Diabetes. The main question it aims to answer is: What is the difference in change in fasting blood glucose and insulin, and hemoglobin A1c (HbA1c) from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide?
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This is a randomized, single-blind, controlled, parallel clinical trial to examine the efficacy and safety of AMPK Charge+® with and without use of semaglutide on glycemic response in adults with prediabetes or Type 2 Diabetes. The main question it aims to answer is: What is the difference in change in fasting blood glucose and insulin, and hemoglobin A1c (HbA1c) from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide? Participants will consume AMPK Charge+® with or without semaglutide injections and will be evaluated for glycemic response parameters.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults 18 years or older (males and females).
- •Females must be unable to become pregnant (for example, after sterilization or being post-menopausal for at least 1 year) OR use birth control with a negative urine pregnancy test at baseline.
- •People who are eligible for semaglutide under standard care, including: prediabetes with HbA1c 6.0% to 6.5% and treatment-naïve; or type 2 diabetes with HbA1c 6.5% to 7.5% and treatment-naïve.
- •Stable body weight (no more than 5 kg gain or loss in the 3 months before baseline).
- •Willing to keep current lifestyle habits and complete clinic visits, questionnaires, records, and diaries.
🚫 You may not be able to join if…
- •Pregnant, breastfeeding, or planning pregnancy during the study.
- •Allergy or intolerance, or a dietary restriction that prevents use of the study products.
- •Personal or family history of MTC (medullary thyroid cancer) or MEN 2.
- •Type 1 diabetes or diabetic ketoacidosis.
- •Recent major surgery (past 3 months) or planned surgery during the study.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults age 18 and older
- ✓Have type 2 diabetes with HbA1c between 6.5% and 7.5%
- ✓Not currently on semaglutide (eligible if eligible for semaglutide per standard of care; T2D must be treatment-naïve and metformin not appropriate)
- ✓Can meet contraception requirements (pregnancy/breastfeeding not allowed)
- ✓No recent major cardiovascular events and no major kidney/liver disease issues per clinician review
- !Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure
- !Not for people who are pregnant or breastfeeding
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- ✓Everyone in this study receives an active treatment — there is no placebo group.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •This study is , so results can't be swayed by expectations. Your medical team always knows what you're getting.
- •There are 2 groups in this study.
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Dietary_supplement: AMPK Charge+®
- Dietary_supplement: AMPK Charge+® with semaglutide
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
Who's running this study?
Sponsor
QuickSilver Scientific
Overseen by David Crowley, MD
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
This is a randomized, single-blind, controlled, parallel clinical trial to examine the efficacy and safety of AMPK Charge+® with and without use of semaglutide on glycemic response in adults with prediabetes or Type 2 Diabetes. The main question it aims to answer is: What is the difference in change in fasting blood glucose and insulin, and hemoglobin A1c (HbA1c) from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide?
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT07195994 · Locations: Ontario