Clinical trial NCT02673203: Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects
Official title: Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: glucose monitoring
hunger levels
food intake
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-02-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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,
* malignancy,
* smoking,
* current or recent steroid use in last 3 months,
* history of current illicit drug use;
* for women: pregnancy, or breastfeeding.

Primary outcomes:
measure: Rate of Changing Glucose Level
timeFrame: 3-5 days
measure: Glucose Peak
timeFrame: 3-5 days
measure: Glucose Nadir
timeFrame: 3-5 days
Secondary outcomes:
measure: Difference in Glucose Peak and Nadir
timeFrame: 3-5 days
measure: Average Daily Hunger Rating
timeFrame: 3-5 days
measure: Nutirion Intake: Energy
timeFrame: 3-5 days
measure: Nutirion Intake: Carbohydrate
timeFrame: 3-5 days
measure: Nutirion Intake: Fat
timeFrame: 3-5 days
measure: Nutirion Intake: Protein
timeFrame: 3-5 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Renata Belfort De Aguiar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: