Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Yale University
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Rate of Changing Glucose Level
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Eligibility 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,
Outcomes
Primary Outcomes
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).
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).
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
- Difference in Glucose Peak and Nadir(3-5 days)
- Average Daily Hunger Rating(3-5 days)
- Nutirion Intake: Energy(3-5 days)
- Nutirion Intake: Carbohydrate(3-5 days)
- Nutirion Intake: Fat(3-5 days)
- Nutirion Intake: Protein(3-5 days)