Inulin Supplementation in Patients With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

Efficacy Evaluation of Inulin Supplementation on Metabolic Control and Akkermansia Muciniphila Levels in Patients With Type 1 Diabetes: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795972
• Other study ID #: 3099
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: veronica ojetti, prof
• Phone: 3396600996
• Email: veronica.ojetti[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Dietary Supplement:
• inulin
patients treated with standard therapy with a supplementation of Inulin 6g twice a day for 3 months.

Other:
• standard therapy
control group (patients treated also with standard therapy)

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 months
Secondary	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.	3 months