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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Carbohydrates consumed last during mealtimes for 6 days
Carbohydrates consumed first during mealtimes for 6 days
Weill Cornell Medicine
New York, New York, United States
Change in incremental glucose peak, under controlled conditions
Time frame: Day 6, Day 12
Change in mean amplitude of glycemic excursion, under controlled conditions
Time frame: 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
Time frame: Day 6, Day 12
Change in incremental glucose peak, under free-living conditions
Time frame: 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
Change in time in range, under free-living conditions
Time during which participant maintained a blood glucose level between 70-180mg/dL
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 6, Day 12
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