Efficacy Evaluation of Inulin Supplementation on Metabolic Control and Akkermansia Muciniphila Levels in Patients With Type 1 Diabetes: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- glycemic control
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
standard therapy
Intervention: standard therapy (Other)
inulin supplementation
Intervention: inulin (Dietary Supplement)
Outcomes
Primary Outcomes
glycemic control
Time Frame: 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 Outcomes
- akkermania levels(3 months)
Investigators
OJETTI VERONICA
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS