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

October 27, 2023 updated by: Weill Medical College of Cornell University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Day 6, Day 12
Day 6, Day 12
Change in mean amplitude of glycemic excursion, under controlled conditions
Time Frame: Day 6, Day 12
Day 6, Day 12
Change in time in range, under controlled conditions
Time Frame: Day 6, Day 12
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
Time Frame: Day 1 through 5, Day 7 through 11
Day 1 through 5, Day 7 through 11
Change in mean amplitude of glycemic excursion, under free-living conditions
Time Frame: Day 1 through 5, Day 7 through 11
Day 1 through 5, Day 7 through 11
Change in time in range, under free-living conditions
Time Frame: Day 1 through 5, Day 7 through 11
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
Time Frame: Day 6, Day 12
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
Time Frame: Day 6, Day 12
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
Time Frame: Day 6, Day 12
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
Time Frame: Day 6, Day 12
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
Time Frame: Day 6, Day 12
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
Time Frame: Day 6, Day 12
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)
Time Frame: Day 6, Day 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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