Type 2 Diabetes
Conditions
Keywords
diabetes, nutrient sequence, food order, continuous glucose monitoring, cgm, t2dm, glycemic excursion, glp-1, ghrelin, insulin, cck, pyy, c-peptide, metformin, diet
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.
Interventions
BEHAVIORALCarbohydrate-Last Meal Sequence
Carbohydrates consumed last during mealtimes for 6 days
BEHAVIORALCarbohydrate-First Meal Sequence
Carbohydrates consumed first during mealtimes for 6 days
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to continuous glucose monitoring readings.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in incremental glucose peak, under controlled conditions | Day 6, Day 12 | — |
| Change in mean amplitude of glycemic excursion, under controlled conditions | Day 6, Day 12 | — |
| Change in time in range, under controlled conditions | Day 6, Day 12 | Time during which participant maintained a blood glucose level between 70-180mg/dL over 8 hour observation period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in time in range, under free-living conditions | Day 1 through 5, Day 7 through 11 | Time during which participant maintained a blood glucose level between 70-180mg/dL |
| Change in postprandial insulin concentration | Day 6, Day 12 | Postprandial concentrations of insulin measured at 30-minute intervals for 180 minutes following standardized meal administration. |
| Change in postprandial c-peptide concentration | Day 6, Day 12 | Postprandial concentrations of c-peptide measured at 30-minute intervals for 180 minutes following standardized meal administration. |
| Change in satiety, as measured by Visual Analog Scale (VAS) | Day 6, Day 12 | 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. |
| Change in postprandial PYY concentration | Day 6, Day 12 | Postprandial concentrations of PYY measured at 30-minute intervals for 180 minutes following standardized meal administration. |
| Change in postprandial GLP-1 concentration | Day 6, Day 12 | Postprandial concentrations GLP-1 measured at 30-minute intervals for 180 minutes following standardized meal administration. |
| Change in postprandial CCK concentration | Day 6, Day 12 | Postprandial concentrations of CCK measured at 30-minute intervals for 180 minutes following standardized meal administration. |
| Change in postprandial ghrelin concentration | Day 6, Day 12 | Postprandial concentrations of ghrelin measured at 30-minute intervals for 180 minutes following standardized meal administration. |
| Change in incremental glucose peak, under free-living conditions | Day 1 through 5, Day 7 through 11 | — |
| Change in mean amplitude of glycemic excursion, under free-living conditions | Day 1 through 5, Day 7 through 11 | — |
Countries
United States
Outcome results
None listed