Diabetes
Conditions
Keywords
glucose monitoring, hunger levels, food intake
Brief summary
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.
Detailed description
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.
Interventions
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.
BEHAVIORALFood 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
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Changing Glucose Level | 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 | 3-5 days | The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl). |
| Glucose Nadir | 3-5 days | The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutirion Intake: Carbohydrate | 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). |
| Difference in Glucose Peak and Nadir | 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). |
| Nutirion Intake: Protein | 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). |
| Nutirion Intake: Fat | 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). |
| Average Daily Hunger Rating | 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. |
| Nutirion Intake: Energy | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Typical Weight Participants Participants with a BMI \<25 kg/m2. | 16 |
| Obese Non-diabetic Pariticpants Non-diabetic participants with a BMI \> 30 kg/m2. | 15 |
| Total | 31 |
Baseline characteristics
| Characteristic | Typical Weight Participants | Total | Obese Non-diabetic Pariticpants |
|---|---|---|---|
| A1c (%) | 5.2 % STANDARD_DEVIATION 0.4 | 5.1 % STANDARD_DEVIATION 0.6 | 5.1 % STANDARD_DEVIATION 0.7 |
| Age, Continuous | 37.3 years STANDARD_DEVIATION 12 | 39 years STANDARD_DEVIATION 13 | 40.4 years STANDARD_DEVIATION 14.1 |
| BMI (kg/m2) | 23.5 kg/m2 STANDARD_DEVIATION 1.7 | 28.3 kg/m2 STANDARD_DEVIATION 5.4 | 33.4 kg/m2 STANDARD_DEVIATION 2.2 |
| Race/Ethnicity, Customized African American | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 11 Participants | 20 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment United States | 16 participants | 31 participants | 15 participants |
| Sex: Female, Male Female | 13 Participants | 25 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
| Weight (kg) | 67.8 kg STANDARD_DEVIATION 12 | 79.3 kg STANDARD_DEVIATION 21.8 | 90.6 kg STANDARD_DEVIATION 12.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Typical Weight Participants | Glucose Nadir | 85.1 mg/dl |
| Obese Non-diabetic Pariticpants | Glucose Nadir | 87.1 mg/dl |
Primary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Typical Weight Participants | Glucose Peak | 119.5 mg/dl |
| Obese Non-diabetic Pariticpants | Glucose Peak | 121.5 mg/dl |
Primary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Typical Weight Participants | Rate of Changing Glucose Level | 0.52 mg/dl/min |
| Obese Non-diabetic Pariticpants | Rate of Changing Glucose Level | 0.44 mg/dl/min |
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Typical Weight Participants | Average Daily Hunger Rating | 5.8 score on a scale |
| Obese Non-diabetic Pariticpants | Average Daily Hunger Rating | 5.6 score on a scale |
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Typical Weight Participants | Difference in Glucose Peak and Nadir | 34.3 mg/dl |
| Obese Non-diabetic Pariticpants | Difference in Glucose Peak and Nadir | 33.9 mg/dl |
Secondary
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).
Time frame: 3-5 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Typical Weight Participants | Nutirion Intake: Carbohydrate | 261.1 g/day |
| Obese Non-diabetic Pariticpants | Nutirion Intake: Carbohydrate | 251.8 g/day |
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Typical Weight Participants | Nutirion Intake: Energy | 2251.5 kcal/day |
| Obese Non-diabetic Pariticpants | Nutirion Intake: Energy | 2167.8 kcal/day |
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Typical Weight Participants | Nutirion Intake: Fat | 92.4 g/day |
| Obese Non-diabetic Pariticpants | Nutirion Intake: Fat | 97.5 g/day |
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Typical Weight Participants | Nutirion Intake: Protein | 99.9 g/day |
| Obese Non-diabetic Pariticpants | Nutirion Intake: Protein | 80.9 g/day |