Blood Lipopolysaccharide (LPS) Rifaximin Study

• Status: Completed
• Trial end date: 2019-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Philip Kern
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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