AMPK Charge+® With/Without Semaglutide for Type 2 Diabetes

Overseen By Marc Moulin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: QuickSilver Scientific

Must be taking: Semaglutide

Must not be taking: OTC medications

Disqualifiers: Pregnancy, Type I diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new dietary supplement, AMPK Charge+®, both alone and with semaglutide (a medication for Type 2 Diabetes), to evaluate their effectiveness in controlling blood sugar in individuals with prediabetes or Type 2 Diabetes. Researchers aim to assess how these treatments impact blood sugar levels and other markers over 84 days. The trial seeks participants with stable weight who are not currently using semaglutide and are willing to maintain their lifestyle habits during the study. As an unphased trial, it offers participants the chance to contribute to early research that could lead to new methods for managing blood sugar levels.

Do I have to stop taking my current medications for the trial?

The trial protocol does not clearly specify if you need to stop taking your current medications. However, it mentions that you should maintain your current lifestyle habits, including medications, as much as possible throughout the study. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that semaglutide is safe for adults with Type 2 Diabetes. The FDA has already approved it for this use, indicating its safety has been thoroughly tested in large groups of people.

For AMPK Charge+®, specific safety data is less available. However, AMPK activation, a key component of AMPK Charge+®, is known to improve insulin sensitivity and blood sugar control, making it a promising option for diabetes treatment.

Since this trial is in its early stages ("not applicable" phase), detailed safety data may be limited. Early-stage trials generally focus on testing the safety of a new treatment in humans. Participants in this trial will contribute to gathering important safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for type 2 diabetes focus on controlling blood sugar levels using medications like metformin or insulin. But AMPK Charge+® is unique because it combines natural ingredients like phospholipids, resveratrol, and berberine, delivered through advanced liposomal and nanoemulsion technology to enhance absorption. This supplement targets cellular energy regulation, potentially offering a new way to support metabolic health. Additionally, when paired with semaglutide, a GLP-1 receptor agonist, it could enhance glycemic control beyond what's possible with standard options, offering a promising new approach for managing type 2 diabetes. Researchers are excited because these combined effects may lead to more effective and holistic management of the condition.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research has shown that AMPK Charge+® can improve insulin use and stabilize blood sugar levels, making it a promising option for managing Type 2 Diabetes. Studies have found that activating AMPK helps balance sugar levels and enhances energy processing. In this trial, some participants will receive AMPK Charge+® alone.

Semaglutide, a proven treatment for Type 2 Diabetes, has received approval from health authorities like the FDA. It boosts the body's insulin response and has been linked to a lower risk of complications. Other participants in this trial will receive a combination of AMPK Charge+® and semaglutide to evaluate whether this combination offers a more effective way to control blood sugar levels compared to using either treatment alone. ^{1 2 6 7 8}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

Adults with prediabetes or Type 2 Diabetes are eligible for this trial. They should be interested in testing a new product, AMPK Charge+®, alone or combined with semaglutide, to see if it can help control blood sugar levels. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

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

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

Agrees to maintain current lifestyle habits as much as possible throughout the study

Exclusion Criteria

Alcohol or drug abuse within the last 12 months

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study

Allergy, sensitivity, intolerance, or dietary restriction preventing use of study products

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AMPK Charge+® with or without semaglutide injections to evaluate glycemic response parameters

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AMPK Charge+®
• Semaglutide

Trial Overview The trial is testing the effectiveness of a product called AMPK Charge+® on its own and in combination with semaglutide injections. The goal is to compare changes in fasting blood glucose, insulin levels, and HbA1c from the start of the study after 84 days.

How Is the Trial Designed?

Group I: AMPK Charge+® Experimental Treatment 1 Intervention

AMPK Charge+® is a dietary supplement comprised of highly purified phospholipids, diindolylmethane, quercetin dihydrate, milk thistle seed extract, resveratrol, and berberine delivered using liposomal and nanoemulsion technology.

Group II: AMPK Charge+® with semaglutide Active Control 1 Intervention

Subcutaneous semaglutide (Ozempic®), a glucagon-like peptide-1 (GLP-1) receptor agonist, is indicated for adults with T2D to improve glycemic control with the safety and efficacy extensively investigated leading to approvals by the United States (U.S.) Food and Drug Administration and Health Canada

Who Is Running the Clinical Trial?

QuickSilver Scientific

Lead Sponsor

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4075959/

AMPK activation: a therapeutic target for type 2 diabetes? - PMC Overall, AMPK activation improves insulin sensitivity and glucose homeostasis, making it an attractive target for T2D and metabolic syndrome. Interestingly, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07195994

Study Details | NCT07195994 | A Clinical Trial to Examine ... This is a randomized, single-blind, controlled, parallel clinical trial to examine the efficacy and safety of AMPK Charge+® with and without ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024097019

Recent advances in anti-inflammation via AMPK activation Identification and characterization of a small molecule AMPK activator that treats key components of type 2 diabetes and the metabolic syndrome.

4. mdpi.com mdpi.com/2072-6643/13/11/4050

AMPK Activity: A Primary Target for Diabetes Prevention ... Tangminling was shown to be effective in reducing insulin resistance in an oral glucose tolerance test, and decreased serum leptin levels. This was accompanied ...

5. nature.com nature.com/articles/s41586-022-04431-8

Low-dose metformin targets the lysosomal AMPK pathway ... Metformin, the most prescribed antidiabetic medicine, has shown other benefits such as anti-ageing and anticancer effects1–4.

6. diabetesjournals.org diabetesjournals.org/diabetes/article/62/7/2164/33795/AMPK-A-Target-for-Drugs-and-Natural-Products-With

AMPK: A Target for Drugs and Natural Products With Effects ... Human studies suggest that activation of muscle AMPK during exercise is normal in patients with type 2 diabetes (31), helping to explain why ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9312068/

State of the Art Regulation by AMPK-Targeting Molecules - PMC It has been shown that AMPK can be dysregulated in different chronic diseases, such as inflammation, diabetes, obesity, and cancer.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1550413106001604

Identification and characterization of a small molecule ... Many of the studies validating AMPK stimulation as a potential target for the treatment of type 2 diabetes, obesity and the metabolic syndrome have utilized ...