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



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:10/22/2017
Start Date:February 2016
End Date:January 2019
Contact:Renata Belfort De Aguiar, MD, PhD
Email:glucose.studies@yale.edu
Phone:+1 (203) 785-6222

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To investigate whether the daily glucose profiles as assessed by continuous glucose
monitoring for 1 week of normal weight, obese, and diabetic individuals relate to hunger
levels and food intake.

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 15 lean healthy
control subjects (BMI <25 kg/m2), 15 obese non-diabetic subjects (BMI > 30 kg/m2), 15 T2DM
subjects who will be age and BMI-matched to obese, non-diabetic subjects, and 15 T1DM
subjects who will be age and BMI matched to control, non-diabetic subjects.

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.

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.
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Phone: 203-785-4183
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