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Inulin Supplementation in Patients With Type 1 Diabetes

Primary Purpose

Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
inulin
standard therapy
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

inulin supplementation

standard therapy

Arm Description

Outcomes

Primary Outcome Measures

glycemic control
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

akkermania levels
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.

Full Information

First Posted
March 21, 2023
Last Updated
April 1, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05795972
Brief Title
Inulin Supplementation in Patients With Type 1 Diabetes
Official Title
Efficacy Evaluation of Inulin Supplementation on Metabolic Control and Akkermansia Muciniphila Levels in Patients With Type 1 Diabetes: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
inulin supplementation
Arm Type
Experimental
Arm Title
standard therapy
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
inulin
Intervention Description
patients treated with standard therapy with a supplementation of Inulin 6g twice a day for 3 months.
Intervention Type
Other
Intervention Name(s)
standard therapy
Intervention Description
control group (patients treated also with standard therapy)
Primary Outcome Measure Information:
Title
glycemic control
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
akkermania levels
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
veronica ojetti, prof
Phone
3396600996
Email
veronica.ojetti@gmail.com
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Ojetti
Phone
3396600996
Email
veronica.ojetti@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Inulin Supplementation in Patients With Type 1 Diabetes

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