Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity

NCT ID: NCT04722354

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2025-12-31

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.

Conditions

Pre Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

ABA group

95 ug 2x/day for 14 days

Group Type: ACTIVE_COMPARATOR

Hyperinsulemic euglycemic clamp

Intervention Type: OTHER

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 Biopsy

Intervention Type: PROCEDURE

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)

Intervention Type: DIETARY_SUPPLEMENT

Those in this group will receive ABA (95 µg ABA and 300 mg of corn starch)

Placebo group

Corn Starch 300 mg for 14 days

Group Type: PLACEBO_COMPARATOR

Hyperinsulemic euglycemic clamp

Intervention Type: OTHER

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 Biopsy

Intervention Type: PROCEDURE

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.

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

Oral abscisic acid (ABA)

Those in this group will receive ABA (95 µg ABA and 300 mg of corn starch)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioTherapeutics Inc.

INDUSTRY

Sponsor Role: collaborator

AdventHealth Translational Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bret Goodpaster, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

AdventHealth Translational Research Institute

Orlando, Florida, United States

Countries

United States

Other Identifiers

1545505

Identifier Type: -

Identifier Source: org_study_id