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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738799
• Other study ID #: 20-03021613
• Status: Completed
• Phase: N/A
• Start date: April 29, 2021
• Est. completion date: July 3, 2023

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 3, 2023
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Carbohydrate-Last Meal Sequence
Carbohydrates consumed last during mealtimes for 6 days
• Carbohydrate-First Meal Sequence
Carbohydrates consumed first during mealtimes for 6 days

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in incremental glucose peak, under controlled conditions		Day 6, Day 12
Primary	Change in mean amplitude of glycemic excursion, under controlled conditions		Day 6, Day 12
Primary	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	Change in incremental glucose peak, under free-living conditions		Day 1 through 5, Day 7 through 11
Secondary	Change in mean amplitude of glycemic excursion, under free-living conditions		Day 1 through 5, Day 7 through 11
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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