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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Carbohydrate-Last Meal Sequence; Behavioral: Carbohydrate-First Meal Sequence

• Registration Number: NCT04738799
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-31
• Study First Submitted QC: 2021-01-31
• Study First Posted: 2021-02-04
• Study Start: 2021-04-29
• Primary Completion: 2023-07-03
• Study Completion: 2023-07-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence	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.
Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence	Carbohydrate-Last 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.
Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence	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.
Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence	Carbohydrate-First 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.

Primary Outcome Measures

Name	Time	Method
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	Day 6, Day 12	Time during which participant maintained a blood glucose level between 70-180mg/dL over 8 hour observation period

Secondary Outcome Measures

Name	Time	Method
Change in incremental glucose peak, under free-living conditions	Day 1 through 5, Day 7 through 11
Change in postprandial GLP-1 concentration	Day 6, Day 12	Postprandial concentrations GLP-1 measured at 30-minute intervals for 180 minutes following standardized meal administration.
Change in postprandial insulin concentration	Day 6, Day 12	Postprandial concentrations of insulin measured at 30-minute intervals for 180 minutes following standardized meal administration.
Change in mean amplitude of glycemic excursion, under free-living conditions	Day 1 through 5, Day 7 through 11
Change in postprandial c-peptide concentration	Day 6, Day 12	Postprandial concentrations of c-peptide measured at 30-minute intervals for 180 minutes following standardized meal administration.
Change in time in range, under free-living conditions	Day 1 through 5, Day 7 through 11	Time during which participant maintained a blood glucose level between 70-180mg/dL
Change in postprandial ghrelin concentration	Day 6, Day 12	Postprandial concentrations of ghrelin measured at 30-minute intervals for 180 minutes following standardized meal administration.
Change in satiety, as measured by Visual Analog Scale (VAS)	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.
Change in postprandial PYY concentration	Day 6, Day 12	Postprandial concentrations of PYY measured at 30-minute intervals for 180 minutes following standardized meal administration.
Change in postprandial CCK concentration	Day 6, Day 12	Postprandial concentrations of CCK measured at 30-minute intervals for 180 minutes following standardized meal administration.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States