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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Carbohydrate-Last Meal Sequence
* Behavioral: Carbohydrate-First Meal Sequence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence<br>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<br>* Carbohydrates consumed last during mealtimes for 6 days<br>Behavioral: Carbohydrate-First Meal Sequence<br>* Carbohydrates consumed first during mealtimes for 6 days<br>|
| Experimental: Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence<br>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<br>* Carbohydrates consumed last during mealtimes for 6 days<br>Behavioral: Carbohydrate-First Meal Sequence<br>* Carbohydrates consumed first during mealtimes for 6 days<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, nutrient sequence, food order, continuous glucose monitoring, cgm, t2dm, glycemic excursion, glp-1, ghrelin, insulin, cck, pyy, c-peptide, metformin, diet