NCT02124512

Dietary Fat, Lipoprotein and Lipopolysaccharide: Role in Insulin Resistance

Completed Phase 2 Results posted Last updated 6 August 2019

What this trial tests

Phase 2 trial testing Rifaximin SSD in Obese in 12 participants. Completed in 31 May 2019.

Timeline

1 March 2015

Primary endpoint
31 May 2019

31 May 2019

Quick facts

Lead sponsor	Philip Kern
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	1 March 2015
Primary completion	31 May 2019
Estimated completion	31 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Rifaximin SSD — full drug profile →
• Placebo

Conditions studied

• Obese — all drugs for Obese →
• Insulin Resistance — all drugs for Insulin Resistance →
• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Philip Kern — full company profile →

Who can join

Adults 35 to 65, any sex, with Obese or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Circulating LPS
  Time frame: 0, 4 and 8 hours at Baseline, and 0, 4 and 8 hours after 12 weeks of treatment
  Plasma lipopolysaccharide (LPS) will be measured both in the fasting state and after a lipid-rich meal in obese subjects (Pre-Treatment: 0, 4 and 8 hr timepoints). The subjects will then be treated with the antibiotic rifaximin for 12 weeks to substantially reduce gut bacteria. LPS measurements at fasting and after a lipid-rich meal will be repeated (Post-Treatment: 0, 4 and 8 hr timepoints). The

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Rifaximin Treatment on Endotoxemia and Insulin Sensitivity in Humans.
   Finlin BS, Zhu B, Boyechko T, Westgate PM, et al · · 2019 · cited 8× · PMID 31428718 · DOI 10.1210/js.2019-00148