Inulin Supplementation in Patients With Type 1 Diabetes

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Diabetes

Treatments: Other: standard therapy; Dietary Supplement: inulin

Study type: Interventional

Funder types: Other

Identifiers

NCT05795972

3099

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

inulin supplementation

Experimental group

Treatment:

Dietary Supplement: inulin

standard therapy

Active Comparator group

Treatment:

Other: standard therapy