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

AdventHealth Translational Research Institute

Status and phase: Active, not recruiting; Phase 2

Conditions: Pre Diabetes

Treatments: Dietary Supplement: Oral abscisic acid (ABA); Other: Placebo; Other: Hyperinsulemic euglycemic clamp; Procedure: Muscle Biopsy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04722354

1545505

Details and patient eligibility

About

The purpose of this study is to determine the effects of oral abscisic acid (ABA) on glucose metabolism in subjects with defined prediabetes.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

48 participants in 2 patient groups, including a placebo group

ABA group

Active Comparator group

Description:

95 ug 2x/day for 14 days

Treatment:

Procedure: Muscle Biopsy

Other: Hyperinsulemic euglycemic clamp

Dietary Supplement: Oral abscisic acid (ABA)

Placebo group

Placebo Comparator group

Description:

Corn Starch 300 mg for 14 days

Treatment:

Procedure: Muscle Biopsy

Other: Hyperinsulemic euglycemic clamp

Other: Placebo