Back to resultsFiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease
Primary Purpose
Type 2 Diabetes Mellitus, Celiac Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Acute test meal with fiber-enriched buckwheat pasta
Acute test meal with corn pasta
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Department of Clinical Medicine and Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fiber-enriched buckwheat pasta
Corn pasta
Arm Description
Acute test meal
Acute test meal
Outcomes
Primary Outcome Measures
Postprandial glucose response
Incremental area under the curve
Secondary Outcome Measures
Full Information
NCT ID
NCT03380988
First Posted
December 12, 2017
Last Updated
December 20, 2017
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT03380988
Brief Title
Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease
Official Title
Fiber-enriched Buckwheat Pasta Reduces Daily Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease: an Acute Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Celiac Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fiber-enriched buckwheat pasta
Arm Type
Experimental
Arm Description
Acute test meal
Arm Title
Corn pasta
Arm Type
Active Comparator
Arm Description
Acute test meal
Intervention Type
Other
Intervention Name(s)
Acute test meal with fiber-enriched buckwheat pasta
Intervention Description
Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
Intervention Type
Other
Intervention Name(s)
Acute test meal with corn pasta
Intervention Description
Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
Primary Outcome Measure Information:
Title
Postprandial glucose response
Description
Incremental area under the curve
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Clinical Medicine and Surgery
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease
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