Pre DiabetesPhase 2ABANCT04722354
Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity
A Phase 2 study testing Hyperinsulemic euglycemic clamp, Muscle Biopsy and Oral abscisic acid (ABA) in people with Pre Diabetes, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of oral abscisic acid (ABA) on glucose metabolism in subjects with defined prediabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- Hyperinsulemic euglycemic clamp, Muscle Biopsy and Oral abscisic acid (ABA)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
AdventHealth Translational Research Institute
Orlando, Florida, 32803
About this study
The purpose of this study is to determine the effects of oral abscisic acid (ABA) on glucose metabolism in subjects with defined prediabetes.
- Conditions
- Pre Diabetes
- Being tested
- Hyperinsulemic euglycemic clamp, Muscle Biopsy, Oral abscisic acid (ABA), Placebo
- Keywords
- metabolism
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulemic euglycemic clampOther
Following a 12-hour overnight fast at the CRU (including abstinence from caffeine containing foods and beverages), insulin sensitivity will be measured using the criterion method of the euglycemic clamp. Participants will have not performed vigorous physical activity for at least the previous 24 h, and be free of acute illness for the prior 2 weeks. An intravenous catheter will be placed in an antecubital vein for subsequent insulin (40 mU/m2-min) and glucose infusions and for stable isotope (6, 6-2H2) infusions to measure insulin sensitivity.
Muscle BiopsyProcedure or surgery
One biopsy taken prior to clamp and a second biopsy taken 30-45 min after the start of the clamp. A biopsy of the Vastus Lateralis muscle will be performed on the leg/thigh using the Bergstrom technique.
Oral abscisic acid (ABA)Dietary supplement
Those in this group will receive ABA (95 µg ABA and 300 mg of corn starch)
PlaceboOther
Those in this group will receive placebo (300 mg cornstarch)
| Study group | Role | What they receive |
|---|---|---|
| ABA group | Active comparator | 95 ug 2x/day for 14 days Receives: Other: Hyperinsulemic euglycemic clamp; Procedure: Muscle Biopsy; Dietary Supplement: Oral abscisic acid (ABA) |
| Placebo group | Placebo comparator | Corn Starch 300 mg for 14 days Receives: Other: Hyperinsulemic euglycemic clamp; Procedure: Muscle Biopsy; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring Adverse Events
Adverse events will be monitored at each visit throughout the duration of the study.
Measured: 10 weeks
Insulin Sensitivity
Rate of glucose disposal, measured by hyperinsulinic euglycemic clamp, normalized to pre-treatment baseline (mg/min)
Measured: After 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start8 Mar 2021
- Primary completion26 Aug 2024
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- BioTherapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Bret Goodpaster, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722354
- Sponsor's protocol ID
- 1545505
- Acronym
- ABA
- Status last verified
- Feb 2026
- First submitted
- 8 Jan 2021
- Last updated
- 9 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT04722354
- Acronym / sponsor ID
- ABA / 1545505
- Conditions
- Pre Diabetes
- Keywords
- metabolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- BioTherapeutics Inc.
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Posted 9 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of oral abscisic acid (ABA) on glucose metabolism in subjects with defined prediabetes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ABA group | Active comparator | Other: Hyperinsulemic euglycemic clamp, Procedure: Muscle Biopsy, Dietary Supplement: Oral abscisic acid (ABA)95 ug 2x/day for 14 days |
| Placebo group | Placebo comparator | Other: Hyperinsulemic euglycemic clamp, Procedure: Muscle Biopsy, Other: PlaceboCorn Starch 300 mg for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 %
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperinsulemic euglycemic clampFollowing a 12-hour overnight fast at the CRU (including abstinence from caffeine containing foods and beverages), insulin sensitivity will be measured using the criterion method of the euglycemic clamp. Participants will have not performed vigorous physical activity for at least the previous 24 h, and be free of acute illness for the prior 2 weeks. An intravenous catheter will be placed in an antecubital vein for subsequent insulin (40 mU/m2-min) and glucose infusions and for stable isotope (6, 6-2H2) infusions to measure insulin sensitivity. | Other | ABA group, Placebo group |
| Muscle BiopsyOne biopsy taken prior to clamp and a second biopsy taken 30-45 min after the start of the clamp. A biopsy of the Vastus Lateralis muscle will be performed on the leg/thigh using the Bergstrom technique. | Procedure or surgery | ABA group, Placebo group |
| Oral abscisic acid (ABA)Those in this group will receive ABA (95 µg ABA and 300 mg of corn starch) | Dietary supplement | ABA group |
| PlaceboThose in this group will receive placebo (300 mg cornstarch) | Other | Placebo group |
Primary outcome
Monitoring Adverse Events
Time frame: 10 weeks
Adverse events will be monitored at each visit throughout the duration of the study.
Insulin Sensitivity
Time frame: After 2 weeks of treatment
Rate of glucose disposal, measured by hyperinsulinic euglycemic clamp, normalized to pre-treatment baseline (mg/min)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bret Goodpaster, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperinsulemic euglycemic clamp, Muscle Biopsy and Oral abscisic acid (ABA) in people with Pre Diabetes, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring Adverse Events (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.