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

NCT ID: NCT03380988

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fiber-enriched buckwheat pasta

Acute test meal

Group Type EXPERIMENTAL

Acute test meal with fiber-enriched buckwheat pasta

Intervention Type OTHER

Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)

Corn pasta

Acute test meal

Group Type ACTIVE_COMPARATOR

Acute test meal with corn pasta

Intervention Type OTHER

Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)

Interventions

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Acute test meal with fiber-enriched buckwheat pasta

Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)

Intervention Type OTHER

Acute test meal with corn pasta

Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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rivellese angela

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Medicine and Surgery

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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175/15

Identifier Type: -

Identifier Source: org_study_id