Postprandial Glycemia in Association With Vascular Disease in Childhood Obesity
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor
研究概览
简要总结
The main purpose of this study is to determine whether treatment with acarbose attenuates post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined by continuous glucose monitoring systems (CGMS). To this effect the current pilot study involves a 6 week intervention with acarbose given to all subjects with either impaired glucose tolerance or an area under the curve of >130 mg/dl during the screening oral glucose tolerance test. Three consecutive days of CGMS are then compared to before and during the intervention. The secondary objective addressed in this protocol is the collection of baseline measures of endothelial function in obese and lean children. Even though the duration of acarbose treatment may be too short to demonstrate a vascular effect, the pre and post intervention data would serve as preliminary data for anticipated future studies that assess the vascular effect of reduced post-prandial blood glucose levels.
详细描述
We are particularly interested in examining whether acarbose lowered the percentage of glucose excursions ≥ 140 mg/dl in a real-life, home environment. At baseline, subjects underwent an oral glucose tolerance test (OGTT) and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obesity (BMI > 97%tile for age and sex matched normative data)
- •Good general health, taking no medication on a chronic basis
- •Age 12-19 yrs, in puberty (girls: breast: Tanner stage II to V, boys: testicular volume >6ml)
- •Girls who are sexually active must use adequate birth control methods(such as barrier method or oral contraception) and must have a negative pregnancy test
- •Normal liver function tests
排除标准
- •Raynaud's syndrome
- •Pregnancy or breastfeeding mothers
- •Anemia (Hct < 35)
- •Baseline creatinine > 1.0 mg
- •Abnormal liver transaminases > 1.5X the upper limit of normal
- •Presence of endocrinopathies (Cushing syndrome, hypothyroidism)
- •Presence or history of gastrointestinal disorders (Inflammatory bowl disease, irritable bowl disease, hernia, ileus)
- •Presence of significant chronic illness of any kind
- •Drug therapy (examples of commonly occurring drug therapy include any drugs to treat asthma, hypertension, dyslipidemia, insulin resistance, depression)
- •Psychiatric disorders
- •History of substance abuse (including anorexic agents)
- •Control Subjects:
- •Inclusion Criteria:
- •Lean (BMI < 85%tile for age and sex matched normative data)
- •Good general health, taking no medication on a chronic basis
- •Age 12-25 yrs, in puberty (girls: breast: Tanner stage II to V, boys: testicular volume >6ml)
- •Girls who are sexually active must use adequate birth control methods (such as barrier method or oral contraception) and must have a negative pregnancy test
- •Exclusion Criteria:
- •Raynaud's syndrome
- •Pregnancy or breastfeeding mothers
- •Presence of endocrinopathies (Cushing syndrome, hypothyroidism Presence of significant chronic illness of any kind
- •Drug therapy (examples of commonly occurring drug therapy include any drugs to treat asthma, dyslipidemia, hypertension, depression)
- •Psychiatric disorders
- •History of substance abuse
- •First degree relative with either T1DM or T2DM
- •Presence of acanthosis nigricans
研究组 & 干预措施
Acarbose
At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
干预措施: Acarbose (Drug)
结局指标
主要结局
Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor
时间窗: After 6 Weeks (post treatment)
次要结局
未报告次要终点