Blood Lipopolysaccharide (LPS) Rifaximin Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Obese, Insulin Resistance, Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT02124512

Run by

Philip Kern

People needed

12

Starts

2015-03-01

Expected to finish

2019-05-31

Last updated by the study team

2019-08-21

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Obese
• Insulin resistance or metabolic syndrome
• Body Mass Index between 27 and 45
• Waist circumference >40" (M) or >35" (F)
• Impaired glucose tolerance (IGT)
• Normal glucose tolerance (NGT) with at least three features of MetS
• A1C <6.5
• Blood pressure 130/85

You may not qualify if…

• Pregnant or breastfeeding
• Recent or unstable cardiovascular disease
• cancer,
• Renal insufficiency (GFR<30)
• Steroid use
• chronic inflammatory conditions
• Anticoagulant use
• Lipodystrophy
• Irritable Bowel Syndrome
• Allergy to local anesthetic
• Lactose intolerance

Where it is running

• University of Kentucky Center for Clinical and Translational Science — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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