Inulin Supplementation in Patients With Type 1 Diabetes

Not Applicable

Recruiting

• Conditions: Diabetes
• Interventions: Dietary Supplement: inulin; Other: standard therapy

• Registration Number: NCT05795972
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-01
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-04
• Primary Completion: 2023-12-31
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with T1D, diagnosed before 35 years of age will be enrolled

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Exclusion Criteria

• advanced complications of T1D (established renal failure, severe retinopathy and diabetic neuropathy)
• BMI> 30 kg / m2.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inulin supplementation	inulin	-
standard therapy	standard therapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy