Status:
ACTIVE_NOT_RECRUITING
Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity
Lead Sponsor:
AdventHealth Translational Research Institute
Collaborating Sponsors:
BioTherapeutics Inc.
Conditions:
Pre Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effects of oral abscisic acid (ABA) on glucose metabolism in subjects with defined prediabetes.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-65
- In good general health as evidenced by medical history or diagnosed with \<specify condition/disease\> or exhibiting \<specify clinical signs or symptoms or physical/oral examination findings\>
- Fasting glucose \>5.6 and\<7.0 mmol/L and/or HbA1C \>5.6 and \<6.5 %
- Ability to take oral medication and be willing to adhere to the \<study intervention\> regimen
- Females currently on hormone replacement therapy (HRT) can participate in the study if they have been on HRT for at least 6 months and will continue to be on HRT during the study.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- Agreement to adhere to Lifestyle Considerations throughout study duration.
- Exclusion Criteria
- Treated or untreated diabetes
- 19\>BMI\<40.0 kg/m2
- Blood pressure (BP) ≤ 150mmHg systolic and ≤ 95 mmHg diastolic
- Current use of medications or antioxidant vitamins or supplements that would impact dependent variables, including glucose metabolism.
- Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, hematological-oncological disease and free of recent infection (prior 2 weeks)
- Pregnancy or lactation
- Treatment with another investigational drug or other intervention within 1 year.
- Current smoker or tobacco use within the past year.
- Disqualifying findings on physical examination include cardiac murmurs, diminished pulses or the presence of bruits in the lower extremities, lower extremity thrombophlebitis, evidence of peripheral neuropathy, paresis or edema.
Exclusion
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04722354
Start Date
March 8 2021
End Date
December 1 2025
Last Update
March 13 2025
Active Locations (1)
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1
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32803