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

NCT02127125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-09-11

Study results available
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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.

Conditions

  • Insulin Sensitivity

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Nicolas Musi, MD. · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-10
Primary Completion
2018-09-30
Completion
2018-09-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127125 on ClinicalTrials.gov