Celiac Disease, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
OTHERAcute test meal with fiber-enriched buckwheat pasta
Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
OTHERAcute test meal with corn pasta
Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial glucose response | 6 hours | Incremental area under the curve |
Countries
Italy
Outcome results
None listed