Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)
NCT ID: NCT02124759
Last Updated: 2021-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2014-04-02
2020-03-30
Brief Summary
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Detailed Description
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* 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.
All subjects are fed both a low fat diet (considered a normal diet) and high fat diet, first one and then the other in no particular sequence. After a washout period participants are fed the other type of high or low fat diet, depending on which diet they were first assigned to in order to compare the effects of the intervention on insulin sensitivity during each diet.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo: maltodextrin, 6 g three times a day
Maltodextrin
This is a control group. Maltodextrin, 6 g three times a day
High Fat diet
The High Fat diet consists of 60% energy from fat (50% saturated), 15% of energy as carbohydrate and 25% from protein consumed while study intervention is being administered.
Low Fat diet
The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.
Sevelamer
Sevelamer: (1.6 g sevelamer + 4.4 g maltodextrin three times a day)
Sevelamer
1.6 g sevelamer + 4.4 g maltodextrin three times a day
High Fat diet
The High Fat diet consists of 60% energy from fat (50% saturated), 15% of energy as carbohydrate and 25% from protein consumed while study intervention is being administered.
Low Fat diet
The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.
Synbiotic
Synbiotic: 5g Oligofructose + 4x1010 Bifidobacterium longum CFU 3x daily during diet
Synbiotic
5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day.
High Fat diet
The High Fat diet consists of 60% energy from fat (50% saturated), 15% of energy as carbohydrate and 25% from protein consumed while study intervention is being administered.
Low Fat diet
The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.
Interventions
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Sevelamer
1.6 g sevelamer + 4.4 g maltodextrin three times a day
Synbiotic
5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day.
Maltodextrin
This is a control group. Maltodextrin, 6 g three times a day
High Fat diet
The High Fat diet consists of 60% energy from fat (50% saturated), 15% of energy as carbohydrate and 25% from protein consumed while study intervention is being administered.
Low Fat diet
The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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American Diabetes Association
OTHER
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Nicolas Musi, MD.
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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Audie L. Murphy VA Hospital, STVHCS
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB #20130458H
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HSC20130459H
Identifier Type: -
Identifier Source: org_study_id