Study of Clinical Response to Acute Metformin By Leveraging Evaluations During a Mixed Meal Tolerance Test for Exploring Glycemia and GeneticS (SCRAMBLED EGGS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,017
- 试验地点
- 1
- 主要终点
- Response to the Mixed Meal Tolerance Test
研究概览
简要总结
The purpose of this research study is to examine whether specific genes (e.g. SLC16A11) affect how human beings respond to food and a medication that is commonly used to treat type 2 diabetes. The food the investigators will be studying is specially prepared to contain protein, carbohydrate, and fat. The drug the investigators are studying is metformin. The investigators hypothesize that physiological responses to the meal and to the medication will differ between carriers and non-carriers of genes associated with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult males or non-pregnant females
- •Age 18-79
- •Able and willing to give consent relevant to genetic investigation
排除标准
- •Women who are pregnant, nursing, or at risk of becoming pregnant
- •Currently taking any medications used for the treatment of diabetes
- •History of liver disease and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times upper limit of normal (ULN)
- •Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation
- •Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
- •Contraindications to safe use of metformin, including planned radiologic or angiographic study requiring contrast within one week of the study completion
- •Planned changes to any prescribed medications, specifically diuretics, during study enrollment
- •Participation in any other interventional study during the study duration
- •Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery
- •Dietary restrictions that would prevent consumption of a MMTT
- •Objection or inability to take metformin
研究组 & 干预措施
Carriers of the SLC16A11 risk allele
Day 1: Mixed Meal Tolerance Test
Day 3-7: 500mg metformin, twice daily
Day 8: Mixed Meal Tolerance Test in presence of Metformin
干预措施: Mixed Meal Tolerance Test (Other)
Carriers of the SLC16A11 risk allele
Day 1: Mixed Meal Tolerance Test
Day 3-7: 500mg metformin, twice daily
Day 8: Mixed Meal Tolerance Test in presence of Metformin
干预措施: Metformin (Drug)
Non-carriers of the SLC16A11 risk allele
Day 1: Mixed Meal Tolerance Test
Day 3-7: 500mg metformin, twice daily
Day 8: Mixed Meal Tolerance Test in presence of Metformin
干预措施: Mixed Meal Tolerance Test (Other)
Non-carriers of the SLC16A11 risk allele
Day 1: Mixed Meal Tolerance Test
Day 3-7: 500mg metformin, twice daily
Day 8: Mixed Meal Tolerance Test in presence of Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Response to the Mixed Meal Tolerance Test
时间窗: 2 hours after the meal
Primary endpoint point: 2 hr glucose after the MMTT Secondary endpoints: 2 hr insulin after the MMTT, change in glucose, insulin, and amino acid and lipid metabolites from baseline to 60 and 120 minutes after the MMTT; change in GLP-1 concentrations from baseline to 5,10, 15, 30, 60, and 120 minutes after the MMTT; and glucose, insulin, and GLP-1 AUC over 120 minutes
次要结局
- Response to Metformin(Day 8 of the study)
研究者
Laura Natalie Brenner
Instructor in Medicine
Massachusetts General Hospital