CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Rifaximin SSD +1 moredrug
Likely dose
Rifaximin SSD 80 mgfrom 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/NCT02124512
NCT02124512Phase 2Completed

Dietary Fat, Lipoprotein and Lipopolysaccharide: Role in Insulin Resistance

Philip Kern·interventional·Posted Apr 28, 2014·Updated Aug 21, 2019

In Brief

A Phase 2 clinical trial evaluating Rifaximin SSD and Placebo for Obese and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Metabolic syndrome is a condition involving elevated levels of fat in the blood, a tendency towards diabetes, hypertension, and too much fat around the abdomen (an increased waistline). Individuals with metabolic syndrome often have impaired glucose tolerance, which is a condition where blood sugar is normal when fasting (before eating), but is too high after drinking a sugary drink. This is due to an abnormality in the body's sensitivity to insulin (insulin resistance), which is due in part to an inability of the muscle to take up glucose. People with metabolic syndrome have inflammation in their fat tissue and in their blood stream, and the changes in the level of inflammatory chemicals produced by cells in your fat tissues will be studied. One possible source of the inflammation may be the bacteria in the intestine. When individuals eat fatty foods, some of the bacterial products become attached to the fat in their blood and then get directed to fat tissue. The investigators wish to determine whether individuals have an excessive amount of inflammation in their fat tissues, and whether this inflammation comes from the bacteria in their intestines. To determine this, the investigators wish to treat individuals with an antibiotic that reduces the bacteria in their intestines and in their blood, and determine whether this reduces their overall level of inflammation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 28, 2014
Enrollment StartMar 1, 2015
Primary CompletionMay 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.2 years ago

Interventions

Rifaximin SSDdrug

Study Drug dosing will be 80 mg SSD once daily

Placeboother

80 mg placebo once daily