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

Yale University

Status: Completed

Conditions: Diabetes

Treatments: Behavioral: Food log; Device: Continuous Glucose Monitoring System (CGMS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02673203

1503015469

1K23DK098286-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Lean Healthy Control

Active Comparator group

Description:

(BMI \<25 kg/m2)

Treatment:

Device: Continuous Glucose Monitoring System (CGMS)

Behavioral: Food log

Obese non-diabetic subject

Active Comparator group

Description:

BMI \> 30 kg/m2

Treatment:

Device: Continuous Glucose Monitoring System (CGMS)

Behavioral: Food log