N/A
N=30
Effect of Endoplasmic Reticulum Stress on Metabolic Function
Insulin Resistance · Diabetes · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00771901 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Body Composition — 39; 39; 37; 39 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tauroursodeoxycholic acid (Drug); placebo (Other); sodium phenylbutyrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Composition |
39; 39; 37; 39; 39; 39 | — |
| SECONDARY Insulin Sensitivity in the Liver |
0.010; 0.009; 0.008; 0.008; 0.012; 0.009 | — |
| SECONDARY VLDL-triglyceride (TG) Concentration |
0.57; 0.74; 0.89; 0.58; 0.75; 0.97 | — |
Summary
Normally, the hormone insulin works to help keep blood sugar normal. However, as a person gains weight, insulin does not work as well and blood sugar tends to be a little higher than normal. This is called "insulin resistance".
Two investigational drugs (not approved by the Food and Drug Administration) for the treatment of high lipid levels or insulin resistance are being examined in this study: one drug is called tauroursodeoxycholic acid (TUDCA), the other is called sodium phenylbutyrate (PBA). This study is designed to test if TUDCA and/or PBA is effective in people who are obese with insulin resistance and high lipids. We hypothesize that pharmacologically-induced decreases in ER stress will improve insulin action and hepatic lipid metabolism in obese subjects.
Eligibility Criteria
Inclusion Criteria
- BMI range 30 to 45
- sedentary (defined as regular exercise 20 g/day
- severe hypertriglyceridemia ( > 400 mg/dL)
- active peptic ulcer disease
- taking cholestyramine or oral contraceptives
- women who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT00771901). 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.