Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrate-Last Meal Sequence | Behavioral | Carbohydrates consumed last during mealtimes for 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Time during which participant maintained a blood glucose level between 70-180mg/dL over 8 hour observation period | Day 6, Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alpana Shukla, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10021 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be blinded to continuous glucose monitoring readings.
| Carbohydrate-First Meal Sequence | Behavioral | Carbohydrates consumed first during mealtimes for 6 days |
|
| Change in time in range, under free-living conditions | Time during which participant maintained a blood glucose level between 70-180mg/dL | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 6, Day 12 |
| D006946 | Hyperinsulinism |