CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 101 enrolled
Drug / intervention
tauroursodeoxycholic acid +2 moredrug
Likely dose
tauroursodeoxycholic acid 1750 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00771901
NCT00771901N/ACompleted

Effect of Endoplasmic Reticulum Stress on Metabolic Function

Washington University School of Medicine·interventional·Posted Oct 15, 2008·Updated May 29, 2018

In Brief

A clinical study evaluating tauroursodeoxycholic acid, placebo, and 1 other intervention for Insulin Resistance and 2 related conditions. Completed, enrolled 101 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 15, 2008
Enrollment StartFeb 1, 2008
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 17.7 years ago

Interventions

tauroursodeoxycholic aciddrug

1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner.

placeboother

7 pills daily for 4 weeks

sodium phenylbutyratedrug

20g/day for four weeks.