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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673203
• Other study ID #: 1503015469
• Secondary ID: 1K23DK098286-01A
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 14, 2017

Study information

• Verified date: April 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 14, 2017
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• 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.

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	3-5 days
Primary	Glucose Peak	The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl).	3-5 days
Primary	Glucose Nadir	The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl).	3-5 days
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).	3-5 days
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.	3-5 days
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).	3-5 days
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).	3-5 days
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).	3-5 days
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).	3-5 days