Actively Recruiting
Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics
Led by Robert Petrella · Updated on 2024-10-15
50
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
Sponsors
R
Robert Petrella
Lead Sponsor
M
Michael Smith Foundation for Health Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 19 and 65 years
- Diagnosed type 2 diabetes with HbA1C between 6.5% and 11% managed by diet only, or healthy volunteers without type 2 diabetes
- Routine dietary habits including three meals per day
- Normal blood parameters including HbA1C >4.0% for healthy volunteers
- Use effective birth control, surgical sterility, or be menopausal for at least 2 years
- Able to understand visit schedules and medication dosing
- Able to avoid supplements affecting blood sugar during the study (e.g., chromium, bitter melon, thiamine, berberine, alpha-lipoic acid, devil's claw, horse chestnut, fenugreek, ginseng, psyllium, cinnamon, garlic, panax)
You will not qualify if you...
- Currently in poor health as determined by the study doctor
- Taking any medications other than vitamins or birth control
- Not eating three regular meals per day
- Current or history of gastrointestinal problems such as inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction
- Travelled abroad within 4 weeks before study entry
- Had surgery within 4 weeks before study entry
- Pregnant or breastfeeding women
- Planning to participate in other investigational drug studies during this study
- Known allergy to the study medication or its components
- History of not following medical regimens or unwilling/unable to attend all scheduled visits
AI-Screening
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Trial Site Locations
Total: 1 location
1
VCHRI Clinical Research Unit
Vancouver, British Columbia, Canada, V5Y2S7
Actively Recruiting
Research Team
M
Michelle Storms
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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