Oat-fiber supplementation for improving glucose metabolism in type 2 diabetes patients
Nutraceutical Improvement of Glucose Metabolism, NAFLD and Insulin Resistance by Oat-fiber Supplementation in Type 2 Diabetes Mellitus Patients
This study is testing if a drink made with oat fiber can help people with type 2 diabetes improve their blood sugar levels and liver health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05654805 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of an oat-fiber drinking supplement on glucose metabolism, insulin resistance, and non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes. The study aims to assess the metabolic benefits of insoluble, poorly fermentable cereal fiber over a shorter intervention period. It employs a triple-blinded randomized controlled trial design to ensure unbiased results. The trial will focus on insulin-naïve patients with overt type 2 diabetes and NAFLD, measuring various metabolic parameters throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are insulin-naïve patients diagnosed with type 2 diabetes and NAFLD.
Not a fit: Patients currently on insulin treatment or those with other severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve glucose metabolism and reduce insulin resistance in patients with type 2 diabetes and NAFLD.
How similar studies have performed: Previous studies have shown promising results with fiber supplementation in metabolic conditions, but this specific approach with insoluble fiber is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin
- Charite University Hospital Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Stefan Kabisch, Dr. med. — Study physician
- Study coordinator: Stefan Kabisch, Dr. med.
- Email: stefan.kabisch@charite.de
- Phone: 0049-30-450514429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.