Clinical trial NCT04722354: Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity
Official title: Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pre Diabetes
Keywords: metabolism
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
Collaborators: name: BioTherapeutics Inc.
First posted: 2021-01-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: a randomized, cross-over, placebo-controlled trial will be employed to evaluate the effects of ABA (95ug) twice a day (190ug total per day) for 14 days on tolerability and insulin sensitivity during a hyperinsulinemic euglycemic clamp.
Primary purpose: OTHER

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 Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18-65
4. 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\>
5. Fasting glucose \>5.6 and\<7.0 mmol/L and/or HbA1C \>5.6 and \<6.5 %
6. Ability to take oral medication and be willing to adhere to the \<study intervention\> regimen
7. 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.
8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
9. Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion Criteria

1. Treated or untreated diabetes
2. 19\>BMI\<40.0 kg/m2
3. Blood pressure (BP) ≤ 150mmHg systolic and ≤ 95 mmHg diastolic
4. Current use of medications or antioxidant vitamins or supplements that would impact dependent variables, including glucose metabolism.
5. 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)
6. Pregnancy or lactation
7. Treatment with another investigational drug or other intervention within 1 year.
8. Current smoker or tobacco use within the past year.
9. 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.

Primary outcomes:
measure: Monitoring adverse events
timeFrame: 10 weeks
measure: Insulin sensitivity
timeFrame: 4-6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Translational Research Institute
state: Florida
Study officials:
affiliation: Principal Investigator
name: Bret Goodpaster, PhD
role: PRINCIPAL_INVESTIGATOR
References: