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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Celiac Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Glucose Metabolism Disorders Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Medicine and Surgery

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute test meal with fiber-enriched buckwheat pasta

Other

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

Acute test meal with corn pasta

Other

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

Primary outcomes

Postprandial glucose response

Time frame: 6 hours

Incremental area under the curve

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Dec 21, 2017
Registry last updated: Dec 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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