Diabetes
Conditions
Brief summary
The aim of this study is to compare the glycemic and metabolic control of type 1 diabetic patients in replacement therapy with insulin, comparing those treated with a supplementation of prebiotics (inulin) and those treated with a placebo. Therefore, the primary objective of the study is represented by the proportion of patients with better glycemic control (basal and post-prandial euglycemia time) and optimal metabolic control (HbA1c, lipid profile, C-RP).
Interventions
DIETARY_SUPPLEMENTinulin
patients treated with standard therapy with a supplementation of Inulin 6g twice a day for 3 months.
OTHERstandard therapy
control group (patients treated also with standard therapy)
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with T1D, diagnosed before 35 years of age will be enrolled
Exclusion criteria
* advanced complications of T1D (established renal failure, severe retinopathy and diabetic neuropathy) * BMI\> 30 kg / m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glycemic control | 3 months | represented by the proportion of patients with better glycemic control (basal and post-prandial euglycemia time) and optimal metabolic control (HbA1c, lipid profile, C-RP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| akkermania levels | 3 months | evaluate the presence of Akkermansia in the gut microbiota at enrollment, and to compare its quantitative modification from the beginning to the end of the therapy, comparing inulin vs a control group. |
Countries
Italy
Contacts
Primary Contactveronica ojetti, prof
Outcome results
None listed