NCT00771901

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

May 29, 2018

Completed
Last Updated

May 29, 2018

Status Verified

April 1, 2018

Enrollment Period

6.8 years

First QC Date

October 10, 2008

Results QC Date

September 15, 2017

Last Update Submit

April 25, 2018

Conditions

Insulin ResistanceDiabetesObesity

Keywords

obesityinsulin resistancetype II diabetes

Outcome Measures

Primary Outcomes (1)

  • Body Composition

    Fat mass (%)

    Baseline and four weeks

Secondary Outcomes (2)

  • Insulin Sensitivity in the Liver

    Baseline and four weeks

  • VLDL-triglyceride (TG) Concentration

    Baseline and four weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects will be given a placebo rather than tauroursodeoxycholic acid.

Other: placebo

tauroursodeoxycholic acid

EXPERIMENTAL

Subjects will receive tauroursodeoxycholic acid for four weeks.

Drug: tauroursodeoxycholic acid

PBA

EXPERIMENTAL

Subjects will receive sodium phenylbutyrate for four weeks.

Drug: sodium phenylbutyrate

Interventions

tauroursodeoxycholic acidDRUG

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

Also known as: TUDCA
tauroursodeoxycholic acid
placeboOTHER

7 pills daily for 4 weeks

Placebo
sodium phenylbutyrateDRUG

20g/day for four weeks.

Also known as: PBA
PBA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI range 30 to 45
  • sedentary (defined as regular exercise \< 1 h per week or \< 2 x/week for the last 6 months)

You may not qualify if:

  • active or previous infection with hepatitis B or C
  • liver diseases
  • history of alcohol abuse
  • current alcohol consumption \> 20 g/day
  • severe hypertriglyceridemia ( \> 400 mg/dL)
  • active peptic ulcer disease
  • taking cholestyramine or oral contraceptives
  • women who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Kars M, Yang L, Gregor MF, Mohammed BS, Pietka TA, Finck BN, Patterson BW, Horton JD, Mittendorfer B, Hotamisligil GS, Klein S. Tauroursodeoxycholic Acid may improve liver and muscle but not adipose tissue insulin sensitivity in obese men and women. Diabetes. 2010 Aug;59(8):1899-905. doi: 10.2337/db10-0308. Epub 2010 Jun 3.

    PMID: 20522594RESULT

MeSH Terms

Conditions

Insulin ResistanceDiabetes MellitusObesityDiabetes Mellitus, Type 2

Interventions

ursodoxicoltaurine4-phenylbutyric acid

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Samuel Klein, M.D.
Organization
Washington University School of Medicine in Saint Louis, Missouri
sklein@wustl.edu
314-362-8708

Study Officials

  • Samuel Klein, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2008

First Posted

October 15, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 29, 2018

Results First Posted

May 29, 2018

Record last verified: 2018-04

Locations

US(1)