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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673203
Recruitment Status : Active, not recruiting
First Posted : February 3, 2016
Results First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Diabetes Device: Continuous Glucose Monitoring System (CGMS) Behavioral: Food log Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects
Actual Study Start Date : February 2016
Actual Primary Completion Date : November 30, 2018
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Active Comparator: Lean Healthy Control
(BMI <25 kg/m2)
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.
Other Name: DEXCOM G4 Platinum

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

Active Comparator: Obese non-diabetic subject
BMI > 30 kg/m2
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.
Other Name: DEXCOM G4 Platinum

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




Primary Outcome Measures :
  1. Rate of Changing Glucose Level [ Time Frame: 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).

  2. Glucose Peak [ Time Frame: 3-5 days ]
    The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl).

  3. Glucose Nadir [ Time Frame: 3-5 days ]
    The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl).


Secondary Outcome Measures :
  1. Difference in Glucose Peak and Nadir [ Time Frame: 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).

  2. Average Daily Hunger Rating [ Time Frame: 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. Nutirion Intake: Energy [ Time Frame: 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).

  4. Nutirion Intake: Carbohydrate [ Time Frame: 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).

  5. Nutirion Intake: Fat [ Time Frame: 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).

  6. Nutirion Intake: Protein [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673203


Locations
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United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06519-1362
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Renata Belfort De Aguiar, MD, PhD Yale School of Medicine
  Study Documents (Full-Text)

Documents provided by Yale University:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02673203    
Other Study ID Numbers: 1503015469
1K23DK098286-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2016    Key Record Dates
Results First Posted: January 22, 2020
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yale University:
glucose monitoring
hunger levels
food intake