Inulin Supplementation in Patients With Type 1 Diabetes

Last updated: April 1, 2023
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Retinopathy

Diabetic Macular Edema

Diabetic Gastroparesis

Treatment

N/A

Clinical Study ID

NCT05795972
3099
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 60
Study Start date:
June 01, 2020
Estimated Completion Date:
May 01, 2024

Connect with a study center

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

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