Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Rate of Changing Glucose Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A1c < 10.5 %
排除标准
- •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,
- •current or recent steroid use in last 3 months,
- •history of current illicit drug use;
- •for women: pregnancy, or breastfeeding.
研究组 & 干预措施
Lean Healthy Control
(BMI <25 kg/m2)
干预措施: Continuous Glucose Monitoring System (CGMS) (Device)
Lean Healthy Control
(BMI <25 kg/m2)
干预措施: Food log (Behavioral)
Obese non-diabetic subject
BMI > 30 kg/m2
干预措施: Continuous Glucose Monitoring System (CGMS) (Device)
Obese non-diabetic subject
BMI > 30 kg/m2
干预措施: Food log (Behavioral)
结局指标
主要结局
Rate of Changing Glucose Level
时间窗: 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).
Glucose Peak
时间窗: 3-5 days
The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl).
Glucose Nadir
时间窗: 3-5 days
The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl).
次要结局
- Difference in Glucose Peak and Nadir(3-5 days)
- Average Daily Hunger Rating(3-5 days)
- Nutirion Intake: Energy(3-5 days)
- Nutirion Intake: Carbohydrate(3-5 days)
- Nutirion Intake: Fat(3-5 days)
- Nutirion Intake: Protein(3-5 days)