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NCT03380988 Clinical Trial

Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease

Type 2 Diabetes Mellitus Clinical Trial

Official title:
Fiber-enriched Buckwheat Pasta Reduces Daily Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease: an Acute Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03380988
Other study ID # 175/15
Secondary ID
Status Completed
Phase N/A
First received December 12, 2017
Last updated December 20, 2017
Start date November 2015
Est. completion date February 2017

Study information
Verified date December 2017
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The intervention was preceded by a 1-week run-in period during which participants underwent continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal infusion rate and insulin-to-glycemic load ratio. The study had a randomized crossover design with each subject studied on 2 occasions at least 1 week apart. Participants were assigned to consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal containing fiber-enriched buckwheat pasta (FBP) or corn pasta (CP), used as control. Over the experimental period, participants underwent CGM, wearing their sensors 7 days/week.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date February 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Age: 20-50 years

- Documented history of celiac disease and type 1 diabetes.

Exclusion Criteria:

- Pregnancy/breast feeding

- Serious microvascular and macrovascular diabetes complications

- Any other chronic or acute disease apart from diabetes seriously affecting health status

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Acute test meal with fiber-enriched buckwheat pasta
Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
• Acute test meal with corn pasta
Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)

Locations
Country Name City State
Italy Department of Clinical Medicine and Surgery Naples

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postprandial glucose response Incremental area under the curve 6 hours
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