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Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity (ABA)

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ClinicalTrials.gov Identifier: NCT04722354
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
BioTherapeutics Inc.
Information provided by (Responsible Party):
AdventHealth Translational Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pre Diabetes Other: Hyperinsulemic euglycemic clamp Procedure: Muscle Biopsy Dietary Supplement: Oral abscisic acid (ABA) Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ABA group
95 ug 2x/day for 14 days
 Other: Hyperinsulemic euglycemic clamp
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.

Procedure: Muscle Biopsy
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.

Dietary Supplement: Oral abscisic acid (ABA)
Those in this group will receive ABA (95 µg ABA and 300 mg of corn starch)
Placebo Comparator: Placebo group
Corn Starch 300 mg for 14 days
 Other: Hyperinsulemic euglycemic clamp
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.

Procedure: Muscle Biopsy
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.

Other: Placebo
Those in this group will receive placebo (300 mg cornstarch)


Outcome Measures
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Primary Outcome Measures :
  1. Monitoring adverse events [ Time Frame: 10 weeks ]
    Adverse events will be monitored at each visit throughout the duration of the study.

  2. Insulin sensitivity [ Time Frame: 4-6 hours ]
    Insulin sensitivity will be measured using hyperinsulinic euglycemic clamp


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04722354


Contacts
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Contact: Recruitment Department 407-303-7100 fh.tri.recruitment@adventhealth.com

Locations
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United States, Florida
AdventHealth Translational Research Institute Recruiting
Orlando, Florida, United States, 32803
Contact: Recruitment Department    407-303-7100    Fh.tri.recruitment@adventhealth.com   
Sponsors and Collaborators
AdventHealth Translational Research Institute
BioTherapeutics Inc.
Investigators
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Principal Investigator: Bret Goodpaster, PhD Principal Investigator
More Information
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Responsible Party: AdventHealth Translational Research Institute
ClinicalTrials.gov Identifier: NCT04722354    
Other Study ID Numbers: 1545505
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AdventHealth Translational Research Institute:
metabolism
Additional relevant MeSH terms:
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Insulin Resistance
Prediabetic State
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
 Endocrine System Diseases
Abscisic Acid
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs