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

Primary Purpose

Pre Diabetes

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hyperinsulemic euglycemic clamp
Muscle Biopsy
Oral abscisic acid (ABA)
Placebo
Sponsored by
AdventHealth Translational Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pre Diabetes focused on measuring metabolism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • AdventHealth Translational Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ABA group

Placebo group

Arm Description

95 ug 2x/day for 14 days

Corn Starch 300 mg for 14 days

Outcomes

Primary Outcome Measures

Monitoring adverse events
Adverse events will be monitored at each visit throughout the duration of the study.
Insulin sensitivity
Insulin sensitivity will be measured using hyperinsulinic euglycemic clamp

Secondary Outcome Measures

Full Information

First Posted
January 8, 2021
Last Updated
July 21, 2023
Sponsor
AdventHealth Translational Research Institute
Collaborators
BioTherapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04722354
Brief Title
Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity
Acronym
ABA
Official Title
Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth Translational Research Institute
Collaborators
BioTherapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes
Keywords
metabolism

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
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
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ABA group
Arm Type
Active Comparator
Arm Description
95 ug 2x/day for 14 days
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Corn Starch 300 mg for 14 days
Intervention Type
Other
Intervention Name(s)
Hyperinsulemic euglycemic clamp
Intervention Description
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
Procedure
Intervention Name(s)
Muscle Biopsy
Intervention Description
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
Dietary Supplement
Intervention Name(s)
Oral abscisic acid (ABA)
Intervention Description
Those in this group will receive ABA (95 µg ABA and 300 mg of corn starch)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Those in this group will receive placebo (300 mg cornstarch)
Primary Outcome Measure Information:
Title
Monitoring adverse events
Description
Adverse events will be monitored at each visit throughout the duration of the study.
Time Frame
10 weeks
Title
Insulin sensitivity
Description
Insulin sensitivity will be measured using hyperinsulinic euglycemic clamp
Time Frame
4-6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria 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 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. Exclusion Criteria 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Recruitment Department
Phone
407-303-7100
Email
fh.tri.recruitment@adventhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bret Goodpaster, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
AdventHealth Translational Research Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruitment Department
Phone
407-303-7100
Email
Fh.tri.recruitment@adventhealth.com

12. IPD Sharing Statement

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Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity

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