Back to resultsThe Impact of Food Order on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carbohydrate-Last Meal Sequence
Carbohydrate-First Meal Sequence
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring diabetes, nutrient sequence, food order, continuous glucose monitoring, cgm, t2dm, glycemic excursion, glp-1, ghrelin, insulin, cck, pyy, c-peptide, metformin, diet
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 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
Sites / Locations
- Weill Cornell MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence
Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change in incremental glucose peak, under controlled conditions
Change in mean amplitude of glycemic excursion, under controlled conditions
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
Secondary Outcome Measures
Change in incremental glucose peak, under free-living conditions
Change in mean amplitude of glycemic excursion, under free-living conditions
Change in time in range, under free-living conditions
Time during which participant maintained a blood glucose level between 70-180mg/dL
Change in postprandial insulin concentration
Postprandial concentrations of insulin measured at 30-minute intervals for 180 minutes following standardized meal administration.
Change in postprandial c-peptide concentration
Postprandial concentrations of c-peptide measured at 30-minute intervals for 180 minutes following standardized meal administration.
Change in postprandial ghrelin concentration
Postprandial concentrations of ghrelin measured at 30-minute intervals for 180 minutes following standardized meal administration.
Change in postprandial PYY concentration
Postprandial concentrations of PYY measured at 30-minute intervals for 180 minutes following standardized meal administration.
Change in postprandial GLP-1 concentration
Postprandial concentrations GLP-1 measured at 30-minute intervals for 180 minutes following standardized meal administration.
Change in postprandial CCK concentration
Postprandial concentrations of CCK measured at 30-minute intervals for 180 minutes following standardized meal administration.
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.
Full Information
NCT ID
NCT04738799
First Posted
January 31, 2021
Last Updated
December 10, 2022
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT04738799
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Participants will be blinded to continuous glucose monitoring readings.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence
Arm Type
Experimental
Arm 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.
Arm Title
Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Carbohydrate-Last Meal Sequence
Intervention Description
Carbohydrates consumed last during mealtimes for 6 days
Intervention Type
Behavioral
Intervention Name(s)
Carbohydrate-First Meal Sequence
Intervention Description
Carbohydrates consumed first during mealtimes for 6 days
Primary Outcome Measure Information:
Title
Change in incremental glucose peak, under controlled conditions
Time Frame
Day 6, Day 12
Title
Change in mean amplitude of glycemic excursion, under controlled conditions
Time Frame
Day 6, Day 12
Title
Change in time in range, under controlled conditions
Description
Time during which participant maintained a blood glucose level between 70-180mg/dL over 8 hour observation period
Time Frame
Day 6, Day 12
Secondary Outcome Measure Information:
Title
Change in incremental glucose peak, under free-living conditions
Time Frame
Day 1 through 5, Day 7 through 11
Title
Change in mean amplitude of glycemic excursion, under free-living conditions
Time Frame
Day 1 through 5, Day 7 through 11
Title
Change in time in range, under free-living conditions
Description
Time during which participant maintained a blood glucose level between 70-180mg/dL
Time Frame
Day 1 through 5, Day 7 through 11
Title
Change in postprandial insulin concentration
Description
Postprandial concentrations of insulin measured at 30-minute intervals for 180 minutes following standardized meal administration.
Time Frame
Day 6, Day 12
Title
Change in postprandial c-peptide concentration
Description
Postprandial concentrations of c-peptide measured at 30-minute intervals for 180 minutes following standardized meal administration.
Time Frame
Day 6, Day 12
Title
Change in postprandial ghrelin concentration
Description
Postprandial concentrations of ghrelin measured at 30-minute intervals for 180 minutes following standardized meal administration.
Time Frame
Day 6, Day 12
Title
Change in postprandial PYY concentration
Description
Postprandial concentrations of PYY measured at 30-minute intervals for 180 minutes following standardized meal administration.
Time Frame
Day 6, Day 12
Title
Change in postprandial GLP-1 concentration
Description
Postprandial concentrations GLP-1 measured at 30-minute intervals for 180 minutes following standardized meal administration.
Time Frame
Day 6, Day 12
Title
Change in postprandial CCK concentration
Description
Postprandial concentrations of CCK measured at 30-minute intervals for 180 minutes following standardized meal administration.
Time Frame
Day 6, Day 12
Title
Change in satiety, as measured by Visual Analog Scale (VAS)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ampadi Karan, BA
Phone
646-962-2426
Email
amk2028@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Casper, BS
Phone
646-962-2424
Email
anc2088@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alpana Shukla, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Casper
Phone
646-962-2424
Email
anc2088@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Alpana Shukla, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Food Order on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring
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