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This randomized, cross-over study compares pasta produced with three different wheat varieties (Senatore Cappelli, Korasan, Claudio). Patients with type 2 diabetes with no pharmacological treatment will be randomized to three different sequences, and asked to eat a standard portion of pasta on three different occasions, four days apart. 3-hour post-prandial interstitial glucose profiles will be recorded using trans-cutaneous sensors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Senatore Cappelli pasta | Experimental |
| |
| Korasan pasta | Experimental |
| |
| Claudio pasta | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan) | Other | A single meal composed of a portion of pasta (with standardized dressing) manufactured with different wheat varieties |
| Measure | Description | Time Frame |
|---|---|---|
| 60-min glucose | Glucose (interstitial monitoring) 60 min after beginning of meal | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 30-min glucose | Glucose (interstitial monitoring) 30 min after beginning of meal | 30 minutes |
| 90-min glucose | Glucose (interstitial monitoring) 90 min after beginning of meal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edoardo Mannucci | Contact | 3387861041 | edoardo.mannucci@unifi.it | |
| Ilaria Dicembrini | Contact | 3333083735 | ilaria.dicembrini@unifi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetologia AOU Careggi | Recruiting | Florence | 50134 | Italy |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Pasta manufactured with current wheat varieties (Claudio) | Other | A single meal composed of a portion of pasta (with standardized dressing) manufactured with different wheat varieties |
|
| 90 minutes |
| 120-min glucose | Glucose (interstitial monitoring) 120 min after beginning of meal | 120 minutes |
| 150-min glucose | Glucose (interstitial monitoring) 150 min after beginning of meal | 150 minutes |
| 180-min glucose | Glucose (interstitial monitoring) 180 min after beginning of meal | 180 minutes |
| Area Under the Curve (AUC) glucose 30 min | Area under glucose (interstitial monitoring) curve 30 min after beginning of meal | 30 minutes |
| AUC glucose 60 min | Area under glucose (interstitial monitoring) curve 60 min after beginning of meal | 60 minutes |
| AUC glucose 90 min | Area under glucose (interstitial monitoring) curve 90 min after beginning of meal | 90 minutes |
| AUC glucose 120 min | Area under glucose (interstitial monitoring) curve 120 min after beginning of meal | 120 minutes |
| AUC glucose 180 min | Area under glucose (interstitial monitoring) curve 180 min after beginning of meal | 180 minutes |
| D004700 | Endocrine System Diseases |