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

Federico II University

Status: Completed

Conditions: Celiac Disease; Type 2 Diabetes Mellitus

Treatments: Other: Acute test meal with fiber-enriched buckwheat pasta; Other: Acute test meal with corn pasta

Study type: Interventional

Funder types: Other

Identifiers

NCT03380988

175/15

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Fiber-enriched buckwheat pasta

Experimental group

Description:

Acute test meal

Treatment:

Other: Acute test meal with fiber-enriched buckwheat pasta

Corn pasta

Active Comparator group

Description:

Acute test meal

Treatment:

Other: Acute test meal with corn pasta