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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Berlin, , Germany
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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