Trial Outcomes & Findings for Inflammation Inhibition in Prediabetic Humans (NCT NCT01977417)

NCT ID: NCT01977417

Last Updated: 2023-09-11

Results Overview

Brachial artery flow-mediated dilation

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: Change from baseline at 4 weeks
• Results posted on: 2023-09-11

Participant Flow

Participant milestones

Measure	Salsalate 3.0 grams/day salsalate (1.5 g twice per day) Salsalate	Placebo Placebo capsule twice per day Placebo
Overall Study STARTED	8	13
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Measure	Salsalate 3.0 grams/day salsalate (1.5 g twice per day) Salsalate	Placebo Placebo capsule twice per day Placebo
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	2	4
Overall Study Female enrollment goal met	0	2

Baseline Characteristics

Inflammation Inhibition in Prediabetic Humans

Baseline characteristics by cohort

Measure	Salsalate n=8 Participants 3.0 grams/day salsalate (1.5 g twice per day) Salsalate	Placebo n=13 Participants Placebo capsule twice per day Placebo	Total n=21 Participants Total of all reporting groups
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
Age, Continuous	37.9 Years STANDARD_DEVIATION 15.7 • n=5 Participants	28.1 Years STANDARD_DEVIATION 10.0 • n=7 Participants	31.8 Years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline at 4 weeks

Brachial artery flow-mediated dilation

Outcome measures

Measure	Salsalate n=5 Participants 3.0 grams/day salsalate (1.5 g twice per day) Salsalate	Placebo n=7 Participants Placebo capsule twice per day Placebo
Aim 1: Vascular Endothelial Function in Obese Prediabetic Adults Before and After 1 Month of Salsalate or Placebo.	5.57 % dilation Standard Deviation 4.35	6.98 % dilation Standard Deviation 6.43

Adverse Events

Salsalate

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

Measure	Salsalate n=8 participants at risk 3.0 grams/day salsalate (1.5 g twice per day) Salsalate	Placebo n=13 participants at risk Placebo capsule twice per day Placebo
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • 4 weeks Participant called in on day 4 and reported they developed punctate rash on bilaterally around wrists and ankles that was itching and red blotchy, but no facial swelling, no trouble breathing or swallowing, no wheezing. Participant was evaluated by study physician over the phone and was instructed to stop medication and then examined in the clinical research unit on day 6 and reported the rash had decreased since day 4 and the rash resolved completely within a few days.	0.00% 0/13 • 4 weeks Participant called in on day 4 and reported they developed punctate rash on bilaterally around wrists and ankles that was itching and red blotchy, but no facial swelling, no trouble breathing or swallowing, no wheezing. Participant was evaluated by study physician over the phone and was instructed to stop medication and then examined in the clinical research unit on day 6 and reported the rash had decreased since day 4 and the rash resolved completely within a few days.

Additional Information

Gary Pierce, PhD

University of Iowa

Phone: 319-335-9487

Email: gary-pierce@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place