An interventional study of tauroursodeoxycholic acid and placebo in Insulin Resistance, Diabetes and Obesity, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-29.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Basic science
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.
A 4-week randomized, controlled trial will be conducted to evaluate the following specific aims in obese subjects:
Determine the effect of treatment with TUDCA or PBA on:
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 101 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
Subjects will be given a placebo rather than tauroursodeoxycholic acid.
Other: placebo
Subjects will receive tauroursodeoxycholic acid for four weeks.
Drug: tauroursodeoxycholic acid
Subjects will receive sodium phenylbutyrate for four weeks.
Drug: sodium phenylbutyrate
1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner.
Also known as: TUDCA
7 pills daily for 4 weeks
20g/day for four weeks.
Also known as: PBA
Body Composition
Fat mass (%)
Time frame: Baseline and four weeks
Insulin Sensitivity in the Liver
HISI (hepatic insulin sensitivity index). HISI is the inverse of the product of endogenous glucose production and plasma insulin concentration and provides an index of how well circulating insulin controls the amount of glucose supplied by the liver. A higher number is indicative of greater insulin sensitivity.
Time frame: Baseline and four weeks
VLDL-triglyceride (TG) Concentration
Time frame: Baseline and four weeks
Participants will be recruited by reviewing the VFH database pf research subjects and by local postings. Potential subjects will be contacted by telephone for an initial pre-screen, at which time the study is discussed and a brief medical history and concomitant medication list is obtained. ICF will be sent to interested subjects.
| Milestone | Placebo | Tauroursodeoxycholic Acid | Sodium Phenylbutyrate |
|---|---|---|---|
| Started | 10 | 10 | 10 |
| Completed | 10 | 10 | 6 |
| Not completed | 0 | 0 | 4 |
| Withdrew: Dissat w/# of study medication (40/day) | 0 | 0 | 4 |
Fat mass (%)
| percentage | Placebo | Tauroursodeoxycholic Acid | Sodium Phenylbutyrate |
|---|---|---|---|
| Before Intervention | 39 ± 7 | 39 ± 8 | 37 ± 6 |
| After Intervention | 39 ± 7 | 39 ± 8 | 39 ± 7 |
HISI (hepatic insulin sensitivity index). HISI is the inverse of the product of endogenous glucose production and plasma insulin concentration and provides an index of how well circulating insulin controls the amount of glucose supplied by the liver. A higher number is indicative of greater insulin sensitivity.
| 100/ (µmol/min * uIU/mL) | Placebo | Tauroursodeoxycholic Acid | Sodium Phenylbutyrate |
|---|---|---|---|
| Before Intervention | 0.010 ± 0.007 | 0.009 ± 0.004 | 0.008 ± 0.003 |
| After Intervention | 0.008 ± 0.004 | 0.012 ± 0.006 | 0.009 ± 0.003 |
| mmol/l | Placebo | Tauroursodeoxycholic Acid | Sodium Phenylbutyrate |
|---|---|---|---|
| Before Intervention | 0.57 ± 0.33 | 0.74 ± 0.50 | 0.89 ± 0.25 |
| After Intervention | 0.58 ± 0.33 | 0.75 ± 0.56 | 0.97 ± 0.18 |
Collected over Adverse event data was collected from the time participants signed the informed consent until 30 days after study completion.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Tauroursodeoxycholic Acid | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Sodium Phenylbutyrate | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Placebo | Tauroursodeoxycholic Acid | Sodium Phenylbutyrate | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 6 | 26 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Placebo | Tauroursodeoxycholic Acid | Sodium Phenylbutyrate | Total |
|---|---|---|---|---|
| Mean | 49 ± 14 | 47 ± 9 | 49 ± 8 | 47 ± 10.6 |
| Sex: Female, Male(Participants) | Placebo | Tauroursodeoxycholic Acid | Sodium Phenylbutyrate | Total |
|---|---|---|---|---|
| Female | 6 | 6 | 2 | 14 |
| Male | 4 | 4 | 4 | 12 |
| Region of Enrollment(participants) | Placebo | Tauroursodeoxycholic Acid | Sodium Phenylbutyrate | Total |
|---|---|---|---|---|
| United States | 10 | 10 | 6 | 26 |
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine