Microvascular Insulin Resistance and Mixed Meal Challenge
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Change from baseline in muscle microvascular blood flow
研究概览
简要总结
Insulin resistance (or pre-diabetes) is diagnosed using the oral glucose tolerance test. However, high blood glucose levels during this test may adversely impact on microvascular function. Investigators will determine whether a liquid mixed meal challenge (from carbohydrate, protein and fat) is a more appropriate test for assessing microvascular-derived insulin resistance.
详细描述
After consuming a meal, 80% of glucose is disposed in skeletal muscle. Our research group has demonstrated that microvascular blood flow in skeletal muscle plays an integral role in this process. Physiological doses of insulin stimulate microvascular blood flow, and that this increase is associated with enhanced glucose uptake by muscle. This microvascular action of insulin is lost during insulin resistance and type 2 diabetes.
The oral glucose tolerance test (GTT) is the gold standard for assessing insulin resistance and pre-diabetes and is used world-wide. However high blood glucose levels following a glucose load may adversely impact on microvascular function. The aim of this project is to determine whether a mixed meal challenge (liquid drink consisting of carbohydrate, fat and protein) is a better test for assessing microvascular-derived insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-70 years.
- •Normal to overweight (BMI 19-35 kg/m2).
- •Normotensive (Seated brachial blood pressure <160/100 mmHg).
- •Considered healthy (HbA1c <6.5 %) or have clinically diagnosed type 2 diabetes.
- •Either have a parent with T2D, or no family history of type 2 diabetes for two generations.
- •Have given signed informed consent to participate in the study
排除标准
- •Age <18 yrs or >70 yrs
- •Morbidly obese with a BMI ≥36 kg/m2
- •History of myocardial infarction or stroke
- •History of malignancy within past 5 years (except for non-melanoma skin cancers)
- •Current smoker
- •History of severe liver disease
- •History of drug or alcohol abuse
- •Elective major surgery during the course of the study
- •Pregnancy/lactation
- •Participation or intention to participate in another clinical research study during the study period.
结局指标
主要结局
Change from baseline in muscle microvascular blood flow
时间窗: 1 hr
Microvascular responses will be measured by contrast enhanced ultrasound before and 1hr after each challenge.
次要结局
- Changes in blood glucose levels(2 hr)
- Changes in plasma insulin levels(2hr)
- Changes in the respiratory exchange ratio (RER)(1 hr)
研究者
Michelle Keske
Senior Research Fellow
Menzies Institute for Medical Research