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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Continuous Glucose Monitoring System (CGMS); Behavioral: Food log

• Registration Number: NCT02673203
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-03
• Primary Completion: 2017-12-14
• Study Completion: 2017-12-14
• Results First Submitted: 2020-01-13
• Results First Submitted QC: 2020-01-21
• Results First Posted: 2020-01-22
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• A1c < 10.5 %

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lean Healthy Control	Food log	(BMI \<25 kg/m2)
Obese non-diabetic subject	Continuous Glucose Monitoring System (CGMS)	BMI \> 30 kg/m2
Lean Healthy Control	Continuous Glucose Monitoring System (CGMS)	(BMI \<25 kg/m2)
Obese non-diabetic subject	Food log	BMI \> 30 kg/m2

Primary Outcome Measures

Name	Time	Method
Rate of Changing Glucose Level	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	3-5 days	The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl).
Glucose Nadir	3-5 days	The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl).

Secondary Outcome Measures

Name	Time	Method
Difference in Glucose Peak and Nadir	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).
Average Daily Hunger Rating	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.
Nutirion Intake: Energy	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).
Nutirion Intake: Carbohydrate	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).
Nutirion Intake: Fat	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).
Nutirion Intake: Protein	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).

Trial Locations

Locations (2)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States