Clinical trial NCT04738799: The Impact of Food Order on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring
Official title: The Impact of Food Order/Nutrient Sequence on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes
nutrient sequence
food order
continuous glucose monitoring
cgm
t2dm
glycemic excursion
glp-1
ghrelin
insulin
cck
pyy
c-peptide
metformin
diet
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in incremental glucose peak, under controlled conditions
timeFrame: Day 6, Day 12
measure: Change in mean amplitude of glycemic excursion, under controlled conditions
timeFrame: Day 6, Day 12
measure: Change in time in range, under controlled conditions
timeFrame: Day 6, Day 12
Secondary outcomes:
measure: Change in incremental glucose peak, under free-living conditions
timeFrame: Day 1 through 5, Day 7 through 11
measure: Change in mean amplitude of glycemic excursion, under free-living conditions
timeFrame: Day 1 through 5, Day 7 through 11
measure: Change in time in range, under free-living conditions
timeFrame: Day 1 through 5, Day 7 through 11
measure: Change in postprandial insulin concentration
timeFrame: Day 6, Day 12
measure: Change in postprandial c-peptide concentration
timeFrame: Day 6, Day 12
measure: Change in postprandial ghrelin concentration
timeFrame: Day 6, Day 12
measure: Change in postprandial PYY concentration
timeFrame: Day 6, Day 12
measure: Change in postprandial GLP-1 concentration
timeFrame: Day 6, Day 12
measure: Change in postprandial CCK concentration
timeFrame: Day 6, Day 12
measure: Change in satiety, as measured by Visual Analog Scale (VAS)
timeFrame: Day 6, Day 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Alpana Shukla, MD
role: PRINCIPAL_INVESTIGATOR
References: