Comparing AMPK Charge+® with and without semaglutide for blood sugar control in adults with prediabetes or type 2 diabetes
A Randomized, Single-blind, Controlled, Parallel 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
This trial will test whether adding semaglutide to AMPK Charge+® improves fasting blood sugar, insulin, and HbA1c in adults with prediabetes or type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | QuickSilver Scientific Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT07195994 on ClinicalTrials.gov |
What this trial studies
This randomized, single-blind, controlled, parallel trial enrolls adults with prediabetes or type 2 diabetes to receive AMPK Charge+® alone or AMPK Charge+® plus semaglutide injections. Participants will be followed for 84 days with measurements of fasting blood glucose, fasting insulin, and hemoglobin A1c to compare changes from baseline between groups. Safety and tolerability of the combination will also be monitored. The main outcome is the difference in glycemic response at Day 84.
Who should consider this trial
Good fit: Adults aged 18 years or older with prediabetes or type 2 diabetes who meet the study's safety and contraception requirements are the intended participants.
Not a fit: People with type 1 diabetes, those on unstable insulin regimens, pregnant or breastfeeding individuals, or those unable to use required contraception may not benefit or be eligible for this trial.
Why it matters
Potential benefit: If successful, the combination could lower fasting glucose and HbA1c more than the supplement alone, potentially improving blood sugar control and slowing progression of prediabetes.
How similar studies have performed: Semaglutide and other GLP‑1 agonists have established glucose‑lowering benefits, but combining them with AMPK Charge+® is a novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males \& females between 18 years of age or older 2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) * Double-barrier method * Intrauterine devices * Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s) * Vasectomy of partner at least 6 months prior to screening * Abstinence and agrees to use contraception if becomes sexually active during this study 3. Individuals eligible for, but not currently taking, semaglutide therapy as per standard-of-care including adults with: 1. Prediabetes (HbA1c 6.0-6.5%) who are treatment naïve 2. Type 2 Diabetes (HbA1c 6.5-7.5%) who are treatment naïve and metformin is inappropriate due to contraindication or intolerance 4. Self-reported stable body weight defined as not having gained or lost more than 5 kg of body weight in the three months prior to baseline 5. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, sleep, use of nicotine, tobacco and cannabinoid products) as much as possible throughout the study 6. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits 7. Provided voluntary, written, informed consent to participate in the study Exclusion Criteria: 1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study 2. Allergy, sensitivity, intolerance, or dietary restriction preventing use of study products 3. Personal or family history of MTC or in patients with MEN 2 4. Unstable metabolic disease or chronic diseases as assessed by the QI 5. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI 6. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3) 7. Type I diabetes or diabetic ketoacidosis 8. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis 9. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months 10. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI 11. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI 12. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable 13. Individuals with an autoimmune disease or are immune compromised 14. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI 15. Self-reported confirmation of blood/bleeding disorders as assessed by the QI 16. Alcohol intake average of \>2 standard drinks per day as assessed by the QI 17. Alcohol or drug abuse within the last 12 months 18. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the study products (See Section 7.3) 19. Clinically significant abnormal laboratory results at screening as assessed by the QI 20. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit 21. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI 22. Individuals who are unable to give informed consent 23. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Where this trial is running
London, Ontario
- KGK Science Inc. — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: David Crowley, MD — KGK Science Inc.
- Study coordinator: Marc Moulin, PhD
- Email: mmoulin@kgkscience.com
- Phone: 2267819094
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.