NCT03201549已完成不适用
The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in serum FGF21 levels
研究概览
简要总结
The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-60
- •BMI 19-25 kg/m2; 19-23 for Asian subjects
- •Stable weight (variation < 3 kg within 6 months of screening visit)
- •Ability to give informed consent in English
- •Use of medically approved form of contraception
排除标准
- •Fasting blood glucose >100
- •Hemoglobin A1C% > 6.5%
- •Fasting triglycerides >150
- •Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
- •Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
- •Uncontrolled hypertension (BP > 160/100 mmHg on or off antihypertensive medication) intravenous drug use
- •Recent weight loss (> 3 kg within 6 months of the screening visit)
- •Gastroparesis
- •Inflammatory or irritable bowel disease
- •Malignancy treated with chemotherapy within the past 3 years
- •Depression or psychosis requiring hospitalization
- •Renal insufficiency (creatinine clearance < 40 ml/min)
- •Transaminases > 2x above the normal range
- •Known liver disease
- •Pregnancy within 6 months of the screening visit
- •Lactation
- •Failure to use medically approved contraceptive methods
- •History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
- •Change in dose of thyroid hormone or antithyroidal medication within 3 months of screening visit
- •History of alcohol abuse within the past 5 years
- •Fructose intolerance
- •Exclusionary medications:
- •Oral steroids
- •Metformin
- •Weight loss medications including nonprescription supplements
结局指标
主要结局
Change in serum FGF21 levels
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
Jody Dushay
Assistant Professor of Medicine
Beth Israel Deaconess Medical Center
研究点 (2)
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