Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1) (MicroB1)
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ClinicalTrials.gov Identifier: NCT02124759 |
Recruitment Status : Unknown
Verified February 2019 by Nicolas Musi, The University of Texas Health Science Center at San Antonio.
Recruitment status was: Active, not recruiting
First Posted : April 28, 2014
Last Update Posted : February 7, 2019
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Condition or disease | Intervention/treatment | Phase |
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Insulin Sensitivity | Drug: Sevelamer Drug: Synbiotic Drug: Maltodextrin | Phase 2 |
We will test the hypothesis that a high fat diet given to lean, normal glucose tolerant subjects will modify gut microbiome composition and enhance intestinal permeability, which will increase plasma LPS concentration, induce an inflammatory response in peripheral tissues (skeletal muscle), and impair insulin signaling and sensitivity. Also we will test the hypothesis that the inflammatory response and insulin resistance caused by high fat ingestion can be ameliorated by administering
- a synbiotic (Bifidobacterium longum R0175 and oligofructose) which protects the intestinal epithelial barrier and decreases intestinal translocation of LPS; and
- sevelamer, an agent which sequesters lipopolysaccharide (LPS) in the gastrointestinal tract limiting its translocation into the circulation.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1) |
Actual Study Start Date : | April 2, 2014 |
Estimated Primary Completion Date : | April 2019 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
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Active Comparator: High fat diet
The high fat diet will provide 60% of energy from fat (of which 50% from saturated fat), 15% of energy as CHO and 25% from protein. subjects will be randomized to receive, in a double-blind fashion
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Drug: Sevelamer
1.6 g sevelamer + 4.4 g maltodextrin three times a day
Other Name: Renvela Drug: Synbiotic 5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day. Drug: Maltodextrin This is a control group. Maltodextrin, 6 g three times a day |
Active Comparator: Low fat diet
The low fat diet will provide 55% of energy from CHO, 20% from fat, and 25% from protein. subjects will be randomized to receive, in a double-blind fashion
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Drug: Sevelamer
1.6 g sevelamer + 4.4 g maltodextrin three times a day
Other Name: Renvela Drug: Synbiotic 5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day. Drug: Maltodextrin This is a control group. Maltodextrin, 6 g three times a day |
- Insulin sensitivity [ Time Frame: At day 28th after put the intervention. ]
- Plasma endotoxin levels [ Time Frame: At baseline, on day 3, and 28 of the intervention. ]
- Gut permeability [ Time Frame: on Day 24 of the intervention. ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Both genders. All races and ethnic groups.
- Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for ≥6 months.
- Hematocrit (HCT)≥ 34%, serum creatinine ≤ 1.4 mg/dl, and normal serum electrolytes, urinalysis, and coagulation tests. Liver function tests (LFTs) up to 2 times normal.
- Stable body weight (±2%) for ≥ 3 months
- Two or less sessions of strenuous exercise/wk for last 6 months.
Exclusion Criteria:
- Presence of diabetes or impaired glucose tolerance based on ADA criteria.
- Current treatment with drugs known to affect glucose and lipid homeostasis. If the subject has been on a stable dose for the past 3 months, the following agents will be permitted: calcium channel blockers, β-blockers, ACE inhibitors, angiotensin receptor blockers, and statins
- History of allergy to sevelamer.
- History of Non-steroidal anti-inflammatory drugs or systemic steroid use for more than a week within 3 months.
- Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsy in accordance with the primary physician.
- Use of agents that affect gut flora (e.g. antibiotics, colestyramine, lactulose, PEG) within 3 months.
- History of heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.
- Poorly controlled blood pressure (systolic BP>170, diastolic BP>95 mmHg).
- Active inflammatory, autoimmune, hepatic, gastrointestinal, malignant, and psychiatric disease.
- History of gastrointestinal surgery or gastrointestinal obstruction within two years.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124759
United States, Texas | |
Audie L. Murphy VA Hospital, STVHCS | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Nicolas Musi, MD. | The University of Texas Health Science Center at San Antonio |
Responsible Party: | Nicolas Musi, Nicolas Musi, MD, The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT02124759 |
Other Study ID Numbers: |
HSC20130459H IRB #20130458H ( Other Grant/Funding Number: American Diabetes Association ) |
First Posted: | April 28, 2014 Key Record Dates |
Last Update Posted: | February 7, 2019 |
Last Verified: | February 2019 |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Sevelamer Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |