Nutraceutical Improvement of Glucose Metabolism, NAFLD and Insulin Resistance by Oat-fiber Supplementation in Type 2 Diabetes Mellitus Patients

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how a specific type of fiber found in oats can help improve the health of patients with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD). Researchers want to find out if taking a daily oat-fiber drink for 12 weeks can lead to better blood sugar control, less insulin resistance, and reduced inflammation in patients who have not started insulin treatment and have moderate to high levels of insulin resistance. The study will involve 92 participants, and it will compare the effects of the oat-fiber supplement to a placebo (a look-alike drink with no active ingredients) to see if there are any significant health benefits.

To join the trial, participants must be between 65 and 74 years old, have a diagnosis of type 2 diabetes, and show signs of insulin resistance and NAFLD. However, those who are currently on insulin, have certain severe health conditions, or have other specific medical issues will not be eligible to participate. Participants can expect to take the supplement daily and attend regular check-ups over the 12 weeks to monitor their health. This study aims to provide clearer insights into how this type of fiber can support better management of diabetes and liver health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • type 2 diabetes mellitus
• • HOMA-IR \> 2.5
• • NAFLD (MR-S \> 5,56 %)
• Exclusion Criteria:
• • insulin treatment
• • diabetes type 1, 3 or 4
• • severe cardiopulmonary, renal, inflammatory, gastrointestinal, psychiatric or endocrine disorder
• • alcohol abuse or excess alcohol intake
• • recent CVD event (\< 3months)
• • relevant liver disease other than NAFLD
• • current cancer diagnosis or treatment
• • allergy or incompatibility to the supplement

Trial Officials