Inflammatory Bowel Disease
Conditions
Brief summary
The purpose of this study is to determine the effect of rosiglitazone on the genes of the colon
Detailed description
The primary aim of the study is to examine the effect of rosiglitazone (Avandia) on gene regulation in colonic epithelium in the absence of pathologic acute and chronic intestinal inflammation. The secondary aims are to determine the effect of rosiglitazone (Avandia) therapy on T cell activation and cytokine expression in the absence of pathologic acute and chronic intestinal inflammation.
Interventions
DRUGRosiglitazone
8mg tablet once a day for 14 days
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
James Lewis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Capable of giving informed consent * Agrees to use a barrier method of birth control for the duration of the study
Exclusion criteria
* History of inflammatory bowel disease * Has taken prescription or over the counter medications in the two weeks prior to enrollment * History of diabetes, heart failure, angina, hypertension, coronary heart disease, cancer, bleeding disorder, HIV, AIDS * Fasting LDL \>160 mg/dl * History of smoking in the year prior to enrollment * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PDK4 mRNA | 14 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rosaglitazone Rosiglitazone: 8mg tablet once a day for 14 days | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Rosaglitazone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
PDK4 mRNA
Time frame: 14 days
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Rosiglitazone | PDK4 mRNA | Pre-treatment | .776 copies/nL |
| Rosiglitazone | PDK4 mRNA | Post-treatment | 1.30 copies/nL |
p-value: 0.01Wilcoxon (Mann-Whitney)