Type 2 DiabetesNCT04738799
The Impact of Food Order on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring
A study testing Carbohydrate-Last Meal Sequence and Carbohydrate-First Meal Sequence in people with Type 2 Diabetes, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Carbohydrate-Last Meal Sequence and Carbohydrate-First Meal Sequence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2021to 3 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Food Order/Nutrient Sequence on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Carbohydrate-Last Meal Sequence, Carbohydrate-First Meal Sequence
- Keywords
- diabetes, nutrient sequence, food order, continuous glucose monitoring, cgm, t2dm, glycemic excursion, glp-1, ghrelin, insulin, cck, pyy, c-peptide, metformin, diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate-Last Meal SequenceBehavioural
Carbohydrates consumed last during mealtimes for 6 days
Carbohydrate-First Meal SequenceBehavioural
Carbohydrates consumed first during mealtimes for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence | Experimental | 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. Receives: Behavioral: Carbohydrate-Last Meal Sequence; Behavioral: Carbohydrate-First Meal Sequence |
| Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence | Experimental | 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. Receives: Behavioral: Carbohydrate-Last Meal Sequence; Behavioral: Carbohydrate-First Meal Sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incremental glucose peak, under controlled conditions
Measured: Day 6, Day 12
Change in mean amplitude of glycemic excursion, under controlled conditions
Measured: 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
Measured: Day 6, Day 12
Secondary outcomes (10)
Change in incremental glucose peak, under free-living conditions
Measured: Day 1 through 5, Day 7 through 11
Change in mean amplitude of glycemic excursion, under free-living conditions
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 6, Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start29 Apr 2021
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alpana Shukla, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738799
- Sponsor's protocol ID
- 20-03021613
- Status last verified
- Oct 2023
- First submitted
- 31 Jan 2021
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Food Order/Nutrient Sequence on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT04738799
- Acronym / sponsor ID
- 20-03021613
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, nutrient sequence, food order, continuous glucose monitoring, cgm, t2dm, glycemic excursion, glp-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence | Experimental | Behavioral: Carbohydrate-Last Meal Sequence, Behavioral: Carbohydrate-First Meal SequenceParticipants 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. |
| Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence | Experimental | Behavioral: Carbohydrate-Last Meal Sequence, Behavioral: Carbohydrate-First Meal SequenceParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Relevant food allergies
- Oral steroid therapy within 90 days of enrollment
- Anti-diabetic medications other than metformin
- History of bariatric surgery
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate-Last Meal SequenceCarbohydrates consumed last during mealtimes for 6 days | Behavioural | Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence, Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence |
| Carbohydrate-First Meal SequenceCarbohydrates consumed first during mealtimes for 6 days | Behavioural | Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence, Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence |
Primary outcome
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 frame: Day 6, Day 12
Time during which participant maintained a blood glucose level between 70-180mg/dL over 8 hour observation period
10 secondary outcomes
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 frame: Day 1 through 5, Day 7 through 11
Change in postprandial insulin concentration
Time frame: Day 6, Day 12
Change in postprandial c-peptide concentration
Time frame: Day 6, Day 12
Change in postprandial ghrelin concentration
Time frame: Day 6, Day 12
Change in postprandial PYY concentration
Time frame: Day 6, Day 12
Change in postprandial GLP-1 concentration
Time frame: Day 6, Day 12
Change in postprandial CCK concentration
Time frame: Day 6, Day 12
Change in satiety, as measured by Visual Analog Scale (VAS)
Time frame: Day 6, Day 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alpana Shukla, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate-Last Meal Sequence and Carbohydrate-First Meal Sequence in people with Type 2 Diabetes, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in incremental glucose peak, under controlled conditions (time frame: Day 6, Day 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.