Phase 2
N=20
Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)
Insulin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT02124759 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Insulin Sensitivity Low Fat Diet — 6.5; 8.2; 9.8 M value (mg/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sevelamer (Drug); Synbiotic (Drug); Maltodextrin (Drug); High Fat diet (Other); Low Fat diet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity Low Fat Diet |
6.5; 8.2; 9.8 | — |
| PRIMARY Insulin Sensitivity High Fat Diet |
6.8; 8.5; 8.8 | >0.05 |
| SECONDARY Plasma Endotoxin Levels |
— | — |
| SECONDARY Gut Permeability |
— | — |
Summary
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)
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02124759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.