The Impact of Food Order on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose… (NCT04738799) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Food Order on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring
United States20 participantsStarted 2021-04-29
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in incremental glucose peak, under controlled conditions
Timeframe: Day 6, Day 12
2
Change in mean amplitude of glycemic excursion, under controlled conditions
Timeframe: Day 6, Day 12
3
Change in time in range, under controlled conditions
Timeframe: Day 6, Day 12
Trial details
NCT IDNCT04738799
SponsorWeill Medical College of Cornell University