Pre Diabetes
Conditions
Keywords
metabolism
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.
Interventions
OTHERHyperinsulemic 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.
PROCEDUREMuscle 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_SUPPLEMENTOral abscisic acid (ABA)
Those in this group will receive ABA (95 µg ABA and 300 mg of corn starch)
OTHERPlacebo
Those in this group will receive placebo (300 mg cornstarch)
Sponsors
AdventHealth Translational Research Institute
BioTherapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring Adverse Events | 10 weeks | Adverse events will be monitored at each visit throughout the duration of the study. |
| Insulin Sensitivity | After 2 weeks of treatment | Rate of glucose disposal, measured by hyperinsulinic euglycemic clamp, normalized to pre-treatment baseline (mg/min) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBret Goodpaster, PhD
Principal Investigator
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
None listed