Insulin Sensitivity Clinical Trial
— MicroB1Official title:
Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)
Verified date | September 2021 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine insulin sensitivity in individuals that are lean normal glucose tolerant subjects after consumption of a normal low fat diet and after a high fat diet and to explore the effects of high fat consumption on the intestinal microbiome, and metabolic endotoxemia.( Aim 1 of the protocol, a separate record is available for Aim 2)
Status | Completed |
Enrollment | 20 |
Est. completion date | March 30, 2020 |
Est. primary completion date | February 23, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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, ß-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. |
Country | Name | City | State |
---|---|---|---|
United States | Audie L. Murphy VA Hospital, STVHCS | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio | American Diabetes Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insulin Sensitivity Low Fat Diet | Skeletal muscle insulin sensitivity measured after 28 days of low fat diet and drug intervention. The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein. | Day 28 | |
Primary | Insulin Sensitivity High Fat Diet | Skeletal muscle insulin sensitivity measured after 28 days of 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. | Day 28 | |
Secondary | Plasma Endotoxin Levels | Endotoxin is a bacterially derived product that we hypothesized would impact insulin sensitivity through pro inflammatory pathways. | At baseline, on day 3, and 28 of the intervention. | |
Secondary | Gut Permeability | Gut permeability is measured using a lactulose/mannitol ingestion assay where urine samples are collected to analyse the ratio of excreted lactulose:mannitol. | on Day 24 of the intervention. |
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