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

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Carbohydrate-Last Meal Sequence; Behavioral: Carbohydrate-First Meal Sequence

Study type: Interventional

Funder types: Other

Identifiers

NCT04738799

20-03021613

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence

Experimental group

Description:

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.

Treatment:

Behavioral: Carbohydrate-Last Meal Sequence

Behavioral: Carbohydrate-First Meal Sequence

Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence

Experimental group

Description:

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.

Treatment:

Behavioral: Carbohydrate-Last Meal Sequence

Behavioral: Carbohydrate-First Meal Sequence