drugset / Trial / NCT02124759
Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)
Phase 2
Completed
20 enrolled
The University of Texas Health Science Center at San Antonio
American Diabetes Association · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine insulin sensitivity in individuals that are lean normal glucose tolerant subjects after consumption of a normal low fat diet and after a high fat diet and to explore the effects of high fat consumption on the intestinal microbiome, and metabolic endotoxemia.( Aim 1 of the protocol, a separate record is available for Aim 2)
Timeline
- Start
- 2014-04-02
- Primary completion
- 2018-02-23
- Completion
- 2020-03-30
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Sevelamer vs Synbiotic; p >0.05; t-test, 2 sided NCT02124759 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bifidobacterium longum R0175 | Unknown | 1 g | — |
| Subject | Oligofructose | Unknown | 5 g | — |
| Comparator | Sevelamer | Other / unclassified | 1.6 g | — |
Indications
No indication recorded.