NCT02127125

Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

In this Aim we will test the hypothesis that lowering lipopolysaccharide (LPS) concentration in the circulation will improve systemic (muscle) inflammation and glucose metabolism in insulin resistant (obese and T2DM) subjects by protecting the intestinal barrier with a synbiotic (Bifidobacterium longum R0175 and oligofructose) or by sequestering LPS in the gastrointestinal lumen with sevelamer.

Conditions

• Insulin Sensitivity

Interventions

Type	Name	Description
DRUG	Maltodextrin	Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
DRUG	Synbiotic	Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
DRUG	Sevelamer	Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks

Timeline

• Start date: 2014-04-10
• Primary completion: 2018-09-01
• Completion: 2018-09-10
• First posted: 2014-04-30
• Last updated: 2020-09-11
• Results posted: 2020-09-11

Locations

1 site across 1 country: United States