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Search / Trial NCT05654805

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

Trial Information

Current as of January 21, 2025

Recruiting

Keywords

Insoluble Cereal Fiber Insulin Resistance Glucose Tolerance Inflammation Incretins

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

Stefan Kabisch, Dr. med.

Principal Investigator

Study physician

About Charite University, Berlin, Germany

Charité - Universitätsmedizin Berlin is a leading academic medical center in Germany, renowned for its commitment to excellence in research, education, and patient care. As one of Europe's largest university hospitals, Charité integrates cutting-edge clinical practices with innovative research initiatives, fostering interdisciplinary collaboration across various medical fields. The institution is dedicated to advancing healthcare through rigorous clinical trials, contributing to the development of new therapies and treatment protocols. With a strong emphasis on translational medicine, Charité aims to bridge the gap between scientific discovery and practical application, ultimately enhancing patient outcomes and public health.

Locations

Berlin, , Germany

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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