Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity

Pre Diabetes Clinical Trial

— ABA  

Official title:

Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04722354
• Other study ID #: 1545505
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 8, 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: AdventHealth Translational Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Pre Diabetes
• Prediabetic State

Intervention

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)

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

Locations

Country	Name	City	State
United States	AdventHealth Translational Research Institute	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute	BioTherapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring adverse events	Adverse events will be monitored at each visit throughout the duration of the study.	10 weeks
Primary	Insulin sensitivity	Insulin sensitivity will be measured using hyperinsulinic euglycemic clamp	4-6 hours