Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease
Not Applicable
Completed
- Conditions
- Type 2 Diabetes MellitusCeliac Disease
- Interventions
- Other: Acute test meal with fiber-enriched buckwheat pastaOther: Acute test meal with corn pasta
- Registration Number
- NCT03380988
- Lead Sponsor
- Federico II University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fiber-enriched buckwheat pasta Acute test meal with fiber-enriched buckwheat pasta Acute test meal Corn pasta Acute test meal with corn pasta Acute test meal
- Primary Outcome Measures
Name Time Method Postprandial glucose response 6 hours Incremental area under the curve
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Clinical Medicine and Surgery
🇮🇹Naples, Italy