Condition: Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) · Sponsor: University Hospital Schleswig-Holstein
The goal of this clinical trial is to prevent the change from prediabetes (a pre-stage of type 2 diabetes mellitus (T2DM)) to T2DM in participants with prediabetes using oral CIR-NA (a nicotinic acid formulation that is designed to be released after reaching the ileum) which targeted the gut microbiota. The main questions it aims to answer are: 1. Is CIR-NA effective and does it prevent the change from prediabetes to T2DM? 2. Is the safety of CIR-NA that was observed in the Phase I clinical trial confirmed in subjects with prediabetes? Researchers will compare CIR-NA to a placebo (a look-alike substance that contains no drug) in terms of an extended safety evaluation including safety laboratory assessments, physical examination, vital signs and 12-lead ECG. Participants will: Take CIR-NA or a placebo every day for 26-weeks. Visit the clinic at week 1 and subsequently once every 4 weeks for checkups and tests. Receive standardized lifestyle recommendations regarding nutrition and physical activity during the intervention.
This description comes directly from the study's public registry record.
Corinna Geisler, PhD · +4943150022446 · corinna.geisler@uksh.de
Matthias Laudes, Prof. Dr. · +49 431 500 22217 · matthias.laudes@uksh.de
Always discuss trial participation with your own doctor first.
| University Medical Center Schleswig-Holstein, Campus Kiel | Kiel, Germany | Recruiting |
| University of Leipzig Medical Center | Leipzig, Germany | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07286747