Prediabetes Stratification by Multi-omics Profile After Food Intake
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Changes in postprandial metabolites response as measured by micro-sampling
研究概览
简要总结
1 in 3 adults have prediabetes in the United States, and many of them will eventually develop diabetes, which has significant public health and economic costs. However, type 2 diabetes (T2D) and prediabetes are heterogeneous groups with different pathological mechanisms, dysfunctions in different processes, and varied disease trajectories. Patient stratifications into subtypes and personalized nutrition interventions are highly needed but not yet available. Metabolic responses (e.g., glucose excursion) after food intake provide a direct observation of personal metabolic control and its association with T2D.
The investigators hope to learn how prediabetes and type 2 diabetes evolve, and specifically what food or exercise can do to mitigate blood sugar response.
详细描述
Screening: The investigators will check fasting blood sugars, HbA1C to determine status (healthy, prediabetes or diabetes).
Enrolled participants will be provided with a Continuous Glucose Monitor (CGM) to measure blood sugars for 10 days and a Fitbit fitness tracker. They will then follow the instructions for each of the 10 days on the monitors:
Day 0: participants will start using the devices and start recording food intake in a food logging app (Cronometer) Day 1-6: Participants will eat a provided portion of white rice (50g of carbohydrates) within 1.5 hrs of waking up). Day 1,3, 5 consume one of the mitigator foods provided (fat (cream), protein (egg whites), or fiber (powdered pea fiber)). Days 2 and 4 no mitigators will be consumed. Day 6 the investigators will ask participants to exercise before eating the rice. Exercise will be moderate for 20 min with constant heart rate level about (220-age)*0.7. During these 6 days participants will be asked to collect microsamples of blood using the Tasso device on the following time points: right after waking up; right before eating their rice; 30 minutes, 1, 2 and 3 hours after the start of the rice meal; right before going to bed
Days 7-9 no intervention, just continue to use devices and log food intake.
Optional- 5 participants who volunteer to repeat this 10 day cycle 3 times.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 18 years of age or older;
- •Not be pregnant;
- •Live close to Stanford Campus
- •Be generally healthy (with no apparent symptoms at the time of enrollment)
- •Patients with prediabetes or diet-controlled or type 2 diabetes or controlled with metformin, will also be allowed to participate.
- •Be willing to provide written informed consent for all study procedures.-
排除标准
- •Major organ diseases,
- •Pregnant or lactating. If a participant will become pregnant while in the study, she will be removed from the study.
- •are on diabetogenic medications (with the exclusion of metformin),
- •have malabsorptive disorders like celiac sprue or similar
- •report heavy alcohol use,
- •use of weight loss medications or specific diets,
- •weight change > 2 kg in the last three weeks,
- •history of bariatric surgery
- •Any medical condition that our physician believes would interfere with study participation or evaluation of results.
- •Mental incapacity and/or cognitive impairment on the part of the patient that would preclude the adequate understanding of, or cooperation with, the study protocol.
结局指标
主要结局
Changes in postprandial metabolites response as measured by micro-sampling
时间窗: 10 days
Dry blood samples will be collected by micro-sampling frequently before and after the standardized meals at 5 time points. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by liquid chromatography mass spectrometry (LC-MS). Both hydrophilic interaction LC and reverse phase LC will be used. Q Exactive will be used for MS. Tandem MS will be collected for annotation. Relative quantification will be used, where the level of metabolites can be compared between samples. Chemical reference will be used for the absolute quantification of targeted metabolites. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.
Comparison of blood glucose levels after the different dietary and exercise mitigators
时间窗: 10 days
Blood glucose value is derived from continuous glucose monitor (CGM) data, expressed in milligrams/deciliter, and measured for 10 days. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.
次要结局
- Changes in personal metabolic states through the day as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)(10 days)
- Changes in personal metabolic states through the day as measured in micro-sampling by Olink proteomics(10 days)
- Changes in postprandial proteomic responses as measured in micro-sampling by Olink(10 days)
研究者
Yue Wu
Postdoctoral Scholar
Stanford University