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Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects

2022年4月8日 更新者：Yale University
To investigate whether the daily glucose profiles as assessed by continuous glucose monitoring for 1 week of normal weight and obese individuals relate to hunger levels and food intake.

研究概览

地位

完全的

条件

干预/治疗

详细说明

To evaluate the effect of blood glucose levels on eating behavior in a population of patients with diabetes in a free-living environment; the investigators plan to study lean healthy control subjects (BMI <25 kg/m2) and obese non-diabetic subjects (BMI > 30 kg/m2).

The participants who qualify will be invited to use the CGMS (DEXCOM G4 Platinum) for up to 7 days. On the visit for placement of the CGMS: 1) the participants will be explained by one of the study physicians how to use a glucometer (FreeStyle or Accu-Check), 2) they will have the CGMS inserted under the skin, and 3) they will be instructed how to fill up the food log (informational brochures are available at the end of the protocol. On the second visit (up to 7 days after the initial visit) the CGMS will be removed from the skin and the glucose meter and food log will be returned to the investigators.

When this study was initially designed, it incorporated 2 additional arms in the study: T1DM and obese T2DM patients. These patients were never recruited for the study.

研究类型

介入性

注册 (实际的)

31

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Connecticut
      • New Haven、Connecticut、美国、06520
        • Yale University School Of Medicine
      • New Haven、Connecticut、美国、06519-1362
        • Yale New Haven Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • A1c < 10.5 %

Exclusion Criteria:

  • BMI <18 (no upper limit),
  • Creatinine > 1.5 mg/dL,
  • Hgb < 10 mg/dL,
  • ALT > 2.5 X ULN,
  • untreated thyroid disease,
  • uncontrolled hypertension,
  • known neurological disorders,
  • untreated psychiatric disorders,
  • use of antidepressants and psychiatric medications,
  • use of weight loss medications in the 6 months prior to the study,
  • malignancy,
  • smoking,
  • current or recent steroid use in last 3 months,
  • history of current illicit drug use;
  • for women: pregnancy, or breastfeeding.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Lean Healthy Control
(BMI <25 kg/m2)
设备：Continuous Glucose Monitoring System (CGMS)
The CGMS consists of 3 parts: sensor, transmitter and monitor. The small sensor measures the glucose levels from the interstitial tissue. The transmitter is attached on top of the sensor and connects wirelessly to the monitor. The sensor is sterile and comes in an unopened package. It has a plastic wire-like tip that is placed under the skin and continuously measures the glucose levels. One of the study physicians will insert the CGMS wire-like tip under the volunteer's skin with the use of the DEXCOM sensor insertion kit. The transmitter is snapped to the sensor pod and the sensor/transmitter unit will be attached to the skin with an adhesive patch. The monitor is the size of a small hand-held device with a digital screen that displays a graph showing the glucose levels from the previous 4-24 hours.
其他名称：
  • DEXCOM G4 Platinum
行为的：Food log
The Food Record will ask about amount and type of food consumed throughout the day. The participants will also register how hungry they are before the meal and how full they feel after they ate, and type and duration of physical activity
有源比较器：Obese non-diabetic subject
BMI > 30 kg/m2
设备：Continuous Glucose Monitoring System (CGMS)
The CGMS consists of 3 parts: sensor, transmitter and monitor. The small sensor measures the glucose levels from the interstitial tissue. The transmitter is attached on top of the sensor and connects wirelessly to the monitor. The sensor is sterile and comes in an unopened package. It has a plastic wire-like tip that is placed under the skin and continuously measures the glucose levels. One of the study physicians will insert the CGMS wire-like tip under the volunteer's skin with the use of the DEXCOM sensor insertion kit. The transmitter is snapped to the sensor pod and the sensor/transmitter unit will be attached to the skin with an adhesive patch. The monitor is the size of a small hand-held device with a digital screen that displays a graph showing the glucose levels from the previous 4-24 hours.
其他名称：
  • DEXCOM G4 Platinum
行为的：Food log
The Food Record will ask about amount and type of food consumed throughout the day. The participants will also register how hungry they are before the meal and how full they feel after they ate, and type and duration of physical activity

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Rate of Changing Glucose Level
大体时间：3-5 days
The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the rate of changing glucose level (mg/dl/min).
3-5 days
Glucose Peak
大体时间：3-5 days
The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl).
3-5 days
Glucose Nadir
大体时间：3-5 days
The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl).
3-5 days

次要结果测量

结果测量
措施说明
大体时间
Difference in Glucose Peak and Nadir
大体时间：3-5 days
The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the difference in glucose peak and nadir (mg/dl).
3-5 days
Average Daily Hunger Rating
大体时间：3-5 days
Average daily hunger was measured using a self-report scale. Hunger is measured on a scale from 1-10. 10 is the most hungry, 1 is the least hungry.
3-5 days
Nutirion Intake: Energy
大体时间：3-5 days
Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily energy intake (kcal/day).
3-5 days
Nutirion Intake: Carbohydrate
大体时间：3-5 days
Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily carbohydrate intake (g/day).
3-5 days
Nutirion Intake: Fat
大体时间：3-5 days
Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily fat intake (g/day).
3-5 days
Nutirion Intake: Protein
大体时间：3-5 days
Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily protein intake (g/day).
3-5 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Yale University

合作者

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

调查人员

  • 首席研究员：Renata Belfort De Aguiar, MD, PhD、Yale School of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年2月1日

初级完成 (实际的)

2017年12月14日

研究完成 (实际的)

2017年12月14日

研究注册日期

首次提交

2016年2月1日

首先提交符合 QC 标准的

2016年2月2日

首次发布 (估计)

2016年2月3日

研究记录更新

最后更新发布 (实际的)

2022年5月5日

上次提交的符合 QC 标准的更新

2022年4月8日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 1503015469
  • 1K23DK098286-01A1 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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