Trial Outcomes & Findings for Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance (NCT NCT01877551)

Last Updated: 2020-01-27

Results Overview

We will examine the ability of insulin to cause muscle to take up insulin. Each subject will receive intravenous insulin for 6 hours to see how much sugar needs to be given intravenously to keep the blood sugar normal, a measure called glucose uptake. We will compare glucose uptake measured as the amount of 20% dextrose that is needed to keep the blood sugar at \~100mg/dl during insulin infusion before and after 30 days of treatment with drug or placebo.

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

Glucose uptake is measured at baseline and 30 days after study intervention

Results posted on

2020-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Tauroursodeoxycholic Acid This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days. Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.	Placebo This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days. Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.
Overall Study STARTED	13	14
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tauroursodeoxycholic Acid This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days. Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.	Placebo This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days. Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.
Overall Study Physician Decision	0	1

Baseline Characteristics

one subject in the control group developed influenza during the study and was excluded from final analysis

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Glucose uptake is measured at baseline and 30 days after study intervention

Outcome measures

Outcome measures
Measure	Tauroursodeoxycholic Acid n=13 Participants This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days. Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.	Placebo n=13 Participants This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days. Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.
Glucose Uptake	0 change in glucose infusion rate (ml/hr) Standard Error 11	8 change in glucose infusion rate (ml/hr) Standard Error 7

SECONDARY outcome

Timeframe: Pre-Treatment and Post 30 day-Treatment

We will measure how much fat is present in each subject before and after treatment with TUDCA or placebo.

Outcome measures

Outcome measures
Measure	Tauroursodeoxycholic Acid n=9 Participants This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days. Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.	Placebo n=7 Participants This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days. Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.
Body Composition Pre	35.7 percentage of body fat Standard Error 2.3	32.6 percentage of body fat Standard Error 2.8
Body Composition Post	35.7 percentage of body fat Standard Error 2.3	31.7 percentage of body fat Standard Error 2.8

SECONDARY outcome

Timeframe: Pre-Treatment and Post 30 day-Treatment

We will use MRI to measure the relative (%) amount of fat in each subject's liver before and after 30 days of treatment. This will allow us to determine if the drug reduces liver fat. This is calculated by subtracting the amount of fat in the liver at the beginning of the study from the amount of fat in the liver after 30 days of treatment. Subjects who have claustrophobia or are unable to undergo MRI will not have this measure performed. Due to these reasons liver MRS was only performed in 10 patients in the tauroursodeoxycholic acid group and 9 subjects in the placebo group

Outcome measures

Outcome measures
Measure	Tauroursodeoxycholic Acid n=10 Participants This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days. Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.	Placebo n=9 Participants This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days. Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.
Liver Fat	-0.3 Change in Percent liver fat Standard Error 0.2	1.2 Change in Percent liver fat Standard Error 0.6

SECONDARY outcome

Timeframe: Pre-Treatment and Post 30 day-Treatment

We will measure liver function tests before and after the study drug to ensure that no abnormalities in liver function occurs with the drug.

Outcome measures

Outcome measures
Measure	Tauroursodeoxycholic Acid n=13 Participants This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days. Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.	Placebo n=13 Participants This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days. Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.
Liver Function Tests ALT-PRE	25 ALT (IU/ml) Standard Error 4	21 ALT (IU/ml) Standard Error 2
Liver Function Tests ALT-Post	19 ALT (IU/ml) Standard Error 3	23 ALT (IU/ml) Standard Error 4

Adverse Events

Tauroursodeoxycholic Acid

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tauroursodeoxycholic Acid n=13 participants at risk This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days. Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.	Placebo n=14 participants at risk This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days. Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.
Infections and infestations influenza	7.7% 1/13 • Number of events 1 • Adverse event data were taken over a 6 week period after initiation of drug or placebo Subjects were followed for 6 weeks	0.00% 0/14 • Adverse event data were taken over a 6 week period after initiation of drug or placebo Subjects were followed for 6 weeks

Additional Information

Dr. Dominic Reeds

Washington University School of Medicine

Phone: 3143628430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Tauroursodeoxycholic Acid n=13 Participants This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days. Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.	Placebo n=14 Participants This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days. Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • one subject in the control group developed influenza during the study and was excluded from final analysis	0 Participants n=7 Participants • one subject in the control group developed influenza during the study and was excluded from final analysis	0 Participants n=5 Participants • one subject in the control group developed influenza during the study and was excluded from final analysis
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants • one subject in the control group developed influenza during the study and was excluded from final analysis	14 Participants n=7 Participants • one subject in the control group developed influenza during the study and was excluded from final analysis	27 Participants n=5 Participants • one subject in the control group developed influenza during the study and was excluded from final analysis
Age, Categorical >=65 years	0 Participants n=5 Participants • one subject in the control group developed influenza during the study and was excluded from final analysis	0 Participants n=7 Participants • one subject in the control group developed influenza during the study and was excluded from final analysis	0 Participants n=5 Participants • one subject in the control group developed influenza during the study and was excluded from final analysis
Age, Continuous	43 years STANDARD_DEVIATION 11 • n=5 Participants	51 years STANDARD_DEVIATION 10 • n=7 Participants	48 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants