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Completed

NCT Number: NCT02673203

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Glucose Monitoring System (CGMS)

Device

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 names: DEXCOM G4 Platinum

Food log

Behavioral

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2016
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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