NCT05826054 Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics
| NCT ID | NCT05826054 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Robert Petrella |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2023-12-01 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to test the investigational product, Montbretin A (MbA) in either individuals with type 2 diabetes (T2D) or healthy participants. The main questions it aims to answer are: * Safety of MbA * Whether MbA has less side effects in comparison to other medications used to treat T2D Participants will: * Be given MbA at increasing amounts (10 mg to 300 mg) over a two-week treatment period, along with standardized meal; * Undergo testing, including blood draws, blood sugar checks, electrocardiogram (ECG) and questionnaires.
Eligibility Criteria
Inclusion Criteria: * Male or female, age ≤ 65 years; ≥19 years; * Have diagnosed type-2 diabetes mellitus with HbA1C between 6.5% to 11% that is currently managed by diet and no other medications or healthy volunteers defined as not having diagnosis of type-2 diabetes mellitus. * Have routine and normal dietary habits that include three meals a day; * Normal hematological parameters as determined through an in-person screening blood draw including HbA1C \>4.0% in healthy volunteers. * Use of an effective barrier method of birth control throughout the study, surgical sterility, or menopausal for at least 2 years; * In the study team's opinion, capable of understanding the visit schedule requirement and study medication dosing requirements. * Be able to avoid all supplements that affect blood sugar for the duration of the study eg. chromium, bitter melon, thiamine, berberine, alpha-lipoic acid, devil's claw, horse chestnut, fenugreek, ginseng, psyllium, cinnamon, garlic and panax. Exclusion Criteria: * Currently in poor health, as determined by the study doctor * Currently on medication, except vitamins and/or birth control * Not eating three regular meals a day * Current or a history of impairment of gastro-intestinal function, including but not limited to inflammatory bowel disease, colonic ulceration, and/or partial intestinal obstruction * Travelled to a foreign country less than four (4) weeks prior to study entry; * Surgery less than four (4) weeks a prior to study entry; * Pregnant or lactating women; * Planning to participate in other investigational drugs while participating in the study; * Known allergy to study medication or its components (non-medicinal ingredients); and * A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits
Contact & Investigator
Robert Petrella, MD, PhD
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT05826054 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 65 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05826054 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05826054 currently recruiting?
Yes, NCT05826054 is actively recruiting participants. Contact the research team at michelle.storms@vch.ca for enrollment information.
Where is the NCT05826054 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT05826054 clinical trial?
NCT05826054 is sponsored by Robert Petrella. The principal investigator is Robert Petrella, MD, PhD at University of British Columbia. The trial plans to enroll 50 participants.
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