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Dietary Supplement
Abscisic Acid for Insulin Resistance and Prediabetes (ABA Trial)
Phase 2
Waitlist Available
Led By Bret Goodpaster, PhD
Research Sponsored by Translational Research Institute for Metabolism and Diabetes, Florida
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 4-6 hours
Summary
This trial will study the effects of ABA on glucose metabolism in people with prediabetes.
Who is the study for?
This trial is for adults aged 18-65 with prediabetes, marked by fasting glucose levels between 5.6 and 7.0 mmol/L or HbA1C between 5.6% and 6.5%. Participants must be in good health, able to take oral medication, agree to lifestyle guidelines, and use effective contraception if necessary. Exclusions include recent other trials, certain physical exam findings, smoking within a year, diabetes treatment, BMI outside of the range of 19-40 kg/m2.
What is being tested?
The study tests how oral abscisic acid (ABA) affects blood sugar control and insulin sensitivity in people with prediabetes compared to a placebo group. It involves procedures like the hyperinsulinemic-euglycemic clamp technique to measure insulin sensitivity and muscle biopsies to examine tissue responses.
What are the potential side effects?
While specific side effects are not listed for ABA in this context as it's under investigation, potential risks may include discomfort from the clamp procedure or muscle biopsy site reactions such as pain or infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-6 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Insulin sensitivity
Monitoring adverse events
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ABA groupActive Control3 Interventions
95 ug 2x/day for 14 days
Group II: Placebo groupPlacebo Group3 Interventions
Corn Starch 300 mg for 14 days
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Who is running the clinical trial?
Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,616 Total Patients Enrolled
AdventHealth Translational Research InstituteLead Sponsor
50 Previous Clinical Trials
5,916 Total Patients Enrolled
BioTherapeutics Inc.Industry Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood sugar levels are between 5.6 and 7.0 mmol/L when fasting, or your HbA1C levels are between 5.6 and 6.5%.You have smoked or used tobacco in the last year.You have diabetes, whether it's being treated or not.Your body mass index (BMI) is between 19 and 40.Your blood pressure should be less than 150 over 95.You have a history of heart problems, stroke, breathing problems, hormone issues, brain or nerve problems, blood cancer, or recent infections.You are between 18 and 65 years old.You are currently taking medications or supplements that could affect how your body processes sugar.
Research Study Groups:
This trial has the following groups:- Group 1: ABA group
- Group 2: Placebo group
Awards:
This trial has 0 awards, including: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.
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