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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
31
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.
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
Yale New Haven Hospital
New Haven, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Rate of Changing Glucose Level
The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the rate of changing glucose level (mg/dl/min).
Time frame: 3-5 days
Glucose Peak
The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl).
Time frame: 3-5 days
Glucose Nadir
The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl).
Time frame: 3-5 days
Difference in Glucose Peak and Nadir
The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the difference in glucose peak and nadir (mg/dl).
Time frame: 3-5 days
Average Daily Hunger Rating
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.
Time frame: 3-5 days
Nutirion Intake: Energy
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).
Time frame: 3-5 days
Nutirion Intake: Carbohydrate
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3-5 days
Nutirion Intake: Fat
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).
Time frame: 3-5 days
Nutirion Intake: Protein
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).
Time frame: 3-5 days