The Impact of Food Order on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring

The Impact of Food Order/Nutrient Sequence on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring

The purpose of this study is to explain the effect of food order/nutrient sequencing on glycemic excursions over a 2 week period, utilizing a device known as a continuous glucose monitor (CGM), for people who have been diagnosed with Type 2 Diabetes Mellitus and treated with metformin. This research study is being done because recent studies demonstrate that besides carbohydrate amount and type, the sequential order of macronutrient consumption during a meal has a significant impact on post-meal glucose levels.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Carbohydrate-Last Meal Sequence; Behavioral: Carbohydrate-First Meal Sequence

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ampadi Karan, BA; Phone Number: 646-962-2426; Email: amk2028@med.cornell.edu
• Study Contact Backup: Name: Anthony Casper, BS; Phone Number: 646-962-2424; Email: anc2088@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Metformin-treated type 2 diabetes of less than 10 years duration
• Must be on a stable dose of metformin for at least 1 month
• HbA1c ≤8.5 percent

Exclusion Criteria:

• Relevant food allergies
• Oral steroid therapy within 90 days of enrollment
• Anti-diabetic medications other than metformin
• History of bariatric surgery
• Pregnant women
• Any participant deemed unsuitable in the investigator's opinion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence; Participants will consume the carbohydrate portion of their prepared meals last during mealtimes for 6 days. They will then consume the carbohydrate portion of their prepared meals first during mealtimes for the following 6 days.	Behavioral: Carbohydrate-Last Meal Sequence; Carbohydrates consumed last during mealtimes for 6 days; Behavioral: Carbohydrate-First Meal Sequence; Carbohydrates consumed first during mealtimes for 6 days
Experimental: Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence; Participants will consume the carbohydrate portion of their prepared meals first during mealtimes for 6 days. They will then consume the carbohydrate portion of their prepared meals last during mealtimes for the following 6 days.	Behavioral: Carbohydrate-Last Meal Sequence; Carbohydrates consumed last during mealtimes for 6 days; Behavioral: Carbohydrate-First Meal Sequence; Carbohydrates consumed first during mealtimes for 6 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in incremental glucose peak, under controlled conditions		Day 6, Day 12
Change in mean amplitude of glycemic excursion, under controlled conditions		Day 6, Day 12
Change in time in range, under controlled conditions	Time during which participant maintained a blood glucose level between 70-180mg/dL over 8 hour observation period	Day 6, Day 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in incremental glucose peak, under free-living conditions		Day 1 through 5, Day 7 through 11
Change in mean amplitude of glycemic excursion, under free-living conditions		Day 1 through 5, Day 7 through 11
Change in time in range, under free-living conditions	Time during which participant maintained a blood glucose level between 70-180mg/dL	Day 1 through 5, Day 7 through 11
Change in postprandial insulin concentration	Postprandial concentrations of insulin measured at 30-minute intervals for 180 minutes following standardized meal administration.	Day 6, Day 12
Change in postprandial c-peptide concentration	Postprandial concentrations of c-peptide measured at 30-minute intervals for 180 minutes following standardized meal administration.	Day 6, Day 12
Change in postprandial ghrelin concentration	Postprandial concentrations of ghrelin measured at 30-minute intervals for 180 minutes following standardized meal administration.	Day 6, Day 12
Change in postprandial PYY concentration	Postprandial concentrations of PYY measured at 30-minute intervals for 180 minutes following standardized meal administration.	Day 6, Day 12
Change in postprandial GLP-1 concentration	Postprandial concentrations GLP-1 measured at 30-minute intervals for 180 minutes following standardized meal administration.	Day 6, Day 12
Change in postprandial CCK concentration	Postprandial concentrations of CCK measured at 30-minute intervals for 180 minutes following standardized meal administration.	Day 6, Day 12
Change in satiety, as measured by Visual Analog Scale (VAS)	Scores are measured on a 100mm VAS. The VAS ranges from 0 to 100, with 0 indicating lower satiety and higher scores indicating greater satiety.	Day 6, Day 12

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Alpana Shukla, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Actual): July 3, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: January 31, 2021
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: diabetes; insulin; metformin; diet; continuous glucose monitoring; ghrelin; c-peptide; nutrient sequence; food order; cgm; t2dm; glycemic excursion; glp-1; cck; pyy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20-03021613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No