Glycemic Index of Pasta From Traditional and Current Wheat Varieties

Diabetes Type 2 Clinical Trial

Official title:

Glycemic Index of Pasta From Traditional and Current Wheat Varieties in Patients With Type 2 Diabetes: a Randomized, Cross-over, Blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05143827
• Other study ID #: 15425-IGGA1
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2022
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: Edoardo Mannucci
• Phone: 3387861041
• Email: edoardo.mannucci[@]unifi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• Body Mass Index (BMI) > 20 kg/m2

• HbA1c < 58 mmol/mol

Exclusion Criteria:

• Current pharmacological therapy for diabetes (of any kind)

• Pregnancy or lactation

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Other:
• Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)
A single meal composed of a portion of pasta (with standardized dressing) manufactured with different wheat varieties
• Pasta manufactured with current wheat varieties (Claudio)
A single meal composed of a portion of pasta (with standardized dressing) manufactured with different wheat varieties

Locations

Country	Name	City	State
Italy	Diabetologia AOU Careggi	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	60-min glucose	Glucose (interstitial monitoring) 60 min after beginning of meal	60 minutes
Secondary	30-min glucose	Glucose (interstitial monitoring) 30 min after beginning of meal	30 minutes
Secondary	90-min glucose	Glucose (interstitial monitoring) 90 min after beginning of meal	90 minutes
Secondary	120-min glucose	Glucose (interstitial monitoring) 120 min after beginning of meal	120 minutes
Secondary	150-min glucose	Glucose (interstitial monitoring) 150 min after beginning of meal	150 minutes
Secondary	180-min glucose	Glucose (interstitial monitoring) 180 min after beginning of meal	180 minutes
Secondary	Area Under the Curve (AUC) glucose 30 min	Area under glucose (interstitial monitoring) curve 30 min after beginning of meal	30 minutes
Secondary	AUC glucose 60 min	Area under glucose (interstitial monitoring) curve 60 min after beginning of meal	60 minutes
Secondary	AUC glucose 90 min	Area under glucose (interstitial monitoring) curve 90 min after beginning of meal	90 minutes
Secondary	AUC glucose 120 min	Area under glucose (interstitial monitoring) curve 120 min after beginning of meal	120 minutes
Secondary	AUC glucose 180 min	Area under glucose (interstitial monitoring) curve 180 min after beginning of meal	180 minutes