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

NCT02673203 | Completed Results

• 2 other identifiers: 15030154691K23DK098286-01A1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Keywords

glucose monitoring; hunger levels; food intake

Outcome Measures

Primary Outcomes (3)

• Rate of Changing Glucose Level

  The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the rate of changing glucose level (mg/dl/min).

  3-5 days

• Glucose Peak

  The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl).

  3-5 days

• Glucose Nadir

  The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl).

  3-5 days

Secondary Outcomes (6)

• 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

Study Arms (2)

Lean Healthy Control

ACTIVE COMPARATOR

(BMI \<25 kg/m2)

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

Obese non-diabetic subject

ACTIVE COMPARATOR

BMI \> 30 kg/m2

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

Interventions

Continuous Glucose Monitoring System (CGMS) DEVICE

The CGMS consists of 3 parts: sensor, transmitter and monitor. The small sensor measures the glucose levels from the interstitial tissue. The transmitter is attached on top of the sensor and connects wirelessly to the monitor. The sensor is sterile and comes in an unopened package. It has a plastic wire-like tip that is placed under the skin and continuously measures the glucose levels. One of the study physicians will insert the CGMS wire-like tip under the volunteer's skin with the use of the DEXCOM sensor insertion kit. The transmitter is snapped to the sensor pod and the sensor/transmitter unit will be attached to the skin with an adhesive patch. The monitor is the size of a small hand-held device with a digital screen that displays a graph showing the glucose levels from the previous 4-24 hours.

Also known as: DEXCOM G4 Platinum

Lean Healthy Control; Obese non-diabetic subject

Food log BEHAVIORAL

The Food Record will ask about amount and type of food consumed throughout the day. The participants will also register how hungry they are before the meal and how full they feel after they ate, and type and duration of physical activity

Lean Healthy Control; Obese non-diabetic subject

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A1c \< 10.5 %

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06519-1362, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Renata Belfort De Aguiar, MD, PhD; Assistant Professor of Medicine (Endocrinology)
• Organization: Yale University School of Medicine

renata.aguiar@yale.edu

(877) 925-3637

Study Officials

• Renata Belfort De Aguiar, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 3, 2016
• Study Start: February 1, 2016
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: May 5, 2022
• Results First Posted: January 22, 2020

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)