Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Monitoring Adverse Events
研究概览
简要总结
The purpose of this study is to determine the effects of oral abscisic acid (ABA) on glucose metabolism in subjects with defined prediabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ABA group
95 ug 2x/day for 14 days
干预措施: Hyperinsulemic euglycemic clamp (Other)
ABA group
95 ug 2x/day for 14 days
干预措施: Muscle Biopsy (Procedure)
ABA group
95 ug 2x/day for 14 days
干预措施: Oral abscisic acid (ABA) (Dietary Supplement)
Placebo group
Corn Starch 300 mg for 14 days
干预措施: Hyperinsulemic euglycemic clamp (Other)
Placebo group
Corn Starch 300 mg for 14 days
干预措施: Muscle Biopsy (Procedure)
Placebo group
Corn Starch 300 mg for 14 days
干预措施: Placebo (Other)
结局指标
主要结局
Monitoring Adverse Events
时间窗: 10 weeks
Adverse events will be monitored at each visit throughout the duration of the study.
Insulin Sensitivity
时间窗: After 2 weeks of treatment
Rate of glucose disposal, measured by hyperinsulinic euglycemic clamp, normalized to pre-treatment baseline (mg/min)
次要结局
未报告次要终点