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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.
Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring.
Design: Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low GI; in the other, high GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat content. Each subject received his usual pre-prandial insulin dosage, followed by a continuous subcutaneous basal insulin infusion for the remainder of the experiment. Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded every 5 minutes.
A total of 14 diet studies (each with two meals) were completed in three men and four women. All subjects completed two diet studies in which two meals were served 195 minutes apart. On one study day, two high GI (> 75) meals were given, and on the other study day, two low GI (< 30) meals were given. The low GI and high GI meals were matched for amount of carbohydrates, protein, and fat based on a weight-maintaining diet for each subject. The order of the study treatment (high or low GI) was randomized. Subjects were not informed as the GI of any meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low glycemic index effect on post-prandial peak | Active Comparator | Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index. |
|
| high glycemic index effect on post-prandial peak | Active Comparator | Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom Seven® Plus Continuous Glucose Monitoring sensor | Device | A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Area Under the Curve for Rise in Breakfast Post-prandial. | Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals. | Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast |
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Inclusion Criteria:
Exclusion Criteria:Any patient who was
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| Name | Affiliation | Role |
|---|---|---|
| W K Ward, MD | Legacy Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Legacy Health System--Holladay Park Campus | Portland | Oregon | 97232 | United States |
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Seven subjects with Type 1 diabetes mellitus on subcutaneous insulin pump therapy were recruited from clinics in Portland, Oregon, USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Glycemic Index, High Glycemic Index | Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with low glycemic index followed by a second study consuming meals with a high glycemic index Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject. |
| FG001 | High Glycemic Index, Low Glycemic Index | Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with high glycemic index followed by a second study consuming meals with a low glycemic index Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index and in one experiment, both meals had a high Glycemic Index. Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Area Under the Curve for Rise in Breakfast Post-prandial. | Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals. | Posted | Mean | Standard Deviation | min x (mmol/l) | Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Glycemic Index Effect on Post-prandial Peak | Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| W. Kenneth Ward | Legacy Health System | 503-413-5171 | kenward503@msn.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index. |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | High Glycemic Index Effect on Post-prandial Peak | Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index. | 0 | 7 | 0 | 7 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |