Inulin Supplementation in Patients With Type 1 Diabetes

NCT05795972 | Unknown

• 1 other identifier: 3099
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• akkermania levels

  3 months

Study Arms (2)

inulin supplementation

EXPERIMENTAL

Dietary Supplement: inulin

standard therapy

ACTIVE COMPARATOR

Other: standard therapy

Interventions

inulin DIETARY_SUPPLEMENT

patients treated with standard therapy with a supplementation of Inulin 6g twice a day for 3 months.

inulin supplementation

standard therapy OTHER

control group (patients treated also with standard therapy)

standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Inulin; Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

veronica ojetti, prof

CONTACT

3396600996; veronica.ojetti@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: June 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: May 1, 2024
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

IT (1)