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Dietary Supplement
Intervention for Type 2 Diabetes (MbA Trial)
Phase 1
Recruiting
Led By Robert Petrella, MD, PhD
Research Sponsored by Robert Petrella
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
MbA Trial Summary
This trial will assess the safety of montbretin A for Type 2 Diabetes sufferers: establishing a safe dosage range and any potential side effects.
Who is the study for?
This trial is for adults with type 2 diabetes who manage their condition through diet alone, have normal blood values, and eat three meals a day. Participants must use effective birth control or be sterile/menopausal. They should understand the study's schedule and medication dosing.Check my eligibility
What is being tested?
The Montbretin A (MbA) clinical trial tests the safety of MbA in treating type 2 diabetes and if it has fewer side effects compared to existing treatments. Patients will take increasing doses of MbA over two weeks alongside standardized meals.See study design
What are the potential side effects?
Potential side effects are not specified but will be monitored through various tests such as blood draws, sugar checks, ECGs, breath testing, and questionnaires to assess any adverse reactions from Montbretin A.
MbA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
MbA Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
In this study, participants will receive increasing dosages of the Study Treatment (Montbretin A, MbA) at each treatment visit. The Study Treatment will be taken with a standardized meal (a meal that has specified quantities of carbohydrates, fats and proteins). At each visit, participants will receive one dose (in pill form) of MbA. As long as they are not experiencing any side effects, this dose will be gradually increased at each study visit (starting from 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, to 300 mg MbA).
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Who is running the clinical trial?
Robert PetrellaLead Sponsor
Michael Smith Foundation for Health ResearchOTHER
19 Previous Clinical Trials
6,074 Total Patients Enrolled
Canadian Glycomics Network (GlycoNet) - Networks of Centres of Excellence (NCE)UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication other than vitamins or birth control.I have or had issues with my digestive system, like inflammatory bowel disease.I manage my type-2 diabetes with diet alone.I am between 19 and 65 years old.I have not had surgery in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age criteria of this research limited to persons over twenty years old?
"This research is seeking adult participants aged between 18 and 65."
Answered by AI
Are there still opportunities to partake in this experiment?
"According to information posted on clinicaltrials.gov, this particular medical study is no longer accepting patients; it was first published in April 1st 2023 and last updated on April 11th of the same year. However, 888 other trials are actively recruiting for participants as we speak."
Answered by AI
To what degree are individuals exposed to risk when taking part in this Intervention?
"In the absence of substantial data, our team at Power has rated Intervention's safety as a 1 on a scale from one to three. This is due to this being Phase 1 trial and hence limited evidence backing its efficacy and safety."
Answered by AI
May I be included as part of this medical experiment?
"Those wishing to join this trial must meet the criteria of 18-65 years old with type 2 diabetes. A maximum of 25 patients will be accepted into the experiment."
Answered by AI
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