CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
Maltodextrin +2 moredrug
Likely dose
Synbiotic 5 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02127125
NCT02127125Phase 2Completed
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Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2)

The University of Texas Health Science Center at San Antonio·interventional·Posted Apr 30, 2014·Updated Sep 11, 2020

In Brief

A Phase 2 clinical trial evaluating Maltodextrin, Synbiotic, and 1 other intervention for Insulin Sensitivity. Completed, enrolled 69 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether microbiome modulation and an experimental reduction in plasma LPS concentration improve inflammation and insulin action in insulin resistant (obese and T2DM) subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsulin Sensitivity
CountriesUnited States
CollaboratorsAmerican Diabetes Association

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 30, 2014
Enrollment StartApr 10, 2014
Primary CompletionSep 1, 2018
Study CompletionSep 10, 2018
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 12.2 years ago

Interventions

Maltodextrindrug

Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.

Synbioticdrug

Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.

Sevelamerdrug

Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks