Trial Outcomes & Findings for ADAM17 and Vascular Function in Diabetes (NCT NCT04557228)

Last Updated: 2026-05-04

Results Overview

Measure of blood flow during oral glucose tolerance test. Leg blood flow measures will be performed non-invasively via Ultrasound.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

baseline and 4 weeks

Results posted on

2026-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Study participants will receive 4 weeks of supplementation with 900mg placebo supplements Placebo: 4 weeks of placebo supplements	Phosphatidylserine Supplementation Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements. Phosphatidylserine: 4 weeks of phosphatidylserine supplements
Overall Study STARTED	19	17
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ADAM17 and Vascular Function in Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=19 Participants Study participants will receive 4 weeks of supplementation with 900mg placebo supplements Placebo: 4 weeks of placebo supplements	Phosphatidylserine Supplementation n=17 Participants Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements. Phosphatidylserine: 4 weeks of phosphatidylserine supplements	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=54 Participants	17 Participants n=60 Participants	36 Participants n=114 Participants
Age, Categorical >=65 years	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Age, Continuous	53 years STANDARD_DEVIATION 6.4 • n=54 Participants	56 years STANDARD_DEVIATION 4.7 • n=60 Participants	55 years STANDARD_DEVIATION 5.9 • n=114 Participants
Sex: Female, Male Female	7 Participants n=54 Participants	7 Participants n=60 Participants	14 Participants n=114 Participants
Sex: Female, Male Male	12 Participants n=54 Participants	10 Participants n=60 Participants	22 Participants n=114 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=54 Participants	0 Participants n=60 Participants	2 Participants n=114 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=54 Participants	16 Participants n=60 Participants	33 Participants n=114 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants	1 Participants n=60 Participants	1 Participants n=114 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Asian	1 Participants n=54 Participants	0 Participants n=60 Participants	1 Participants n=114 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Black or African American	1 Participants n=54 Participants	2 Participants n=60 Participants	3 Participants n=114 Participants
Race (NIH/OMB) White	17 Participants n=54 Participants	15 Participants n=60 Participants	32 Participants n=114 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Region of Enrollment United States	19 participants n=54 Participants	17 participants n=60 Participants	36 participants n=114 Participants

PRIMARY outcome

Timeframe: baseline and 4 weeks

Measure of blood flow during oral glucose tolerance test. Leg blood flow measures will be performed non-invasively via Ultrasound.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Study participants will receive 4 weeks of supplementation with 900mg placebo supplements Placebo: 4 weeks of placebo supplements	Phosphatidylserine Supplementation n=16 Participants Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements. Phosphatidylserine: 4 weeks of phosphatidylserine supplements
Change in Insulin-stimulated Blood Flow	-70.80 mL/min Standard Deviation 264.87	24.79 mL/min Standard Deviation 174.76

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Flow mediated dilation (FMD) in arm and passive limb movement (PLM) in the leg. Blood flow measures will be performed non-invasively via Ultrasound.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Study participants will receive 4 weeks of supplementation with 900mg placebo supplements Placebo: 4 weeks of placebo supplements	Phosphatidylserine Supplementation n=16 Participants Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements. Phosphatidylserine: 4 weeks of phosphatidylserine supplements
Percent Change in Vascular Function	0.54 Percent Change in Vascular function Standard Deviation 1.59	0.41 Percent Change in Vascular function Standard Deviation 1.68

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Phosphatidylserine Supplementation

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=19 participants at risk Study participants will receive 4 weeks of supplementation with 900mg placebo supplements Placebo: 4 weeks of placebo supplements	Phosphatidylserine Supplementation n=17 participants at risk Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements. Phosphatidylserine: 4 weeks of phosphatidylserine supplements
Cardiac disorders Hypertension	10.5% 2/19 • Number of events 3 • baseline (day 0) to final (week 4)	11.8% 2/17 • Number of events 3 • baseline (day 0) to final (week 4)

Other adverse events

Other adverse events
Measure	Placebo n=19 participants at risk Study participants will receive 4 weeks of supplementation with 900mg placebo supplements Placebo: 4 weeks of placebo supplements	Phosphatidylserine Supplementation n=17 participants at risk Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements. Phosphatidylserine: 4 weeks of phosphatidylserine supplements
Nervous system disorders Neuropathy	0.00% 0/19 • baseline (day 0) to final (week 4)	5.9% 1/17 • Number of events 1 • baseline (day 0) to final (week 4)
General disorders Covid-19 Infection	5.3% 1/19 • Number of events 1 • baseline (day 0) to final (week 4)	0.00% 0/17 • baseline (day 0) to final (week 4)
Endocrine disorders Hyperglycemia	5.3% 1/19 • Number of events 1 • baseline (day 0) to final (week 4)	0.00% 0/17 • baseline (day 0) to final (week 4)
Immune system disorders Hypersensitivity	5.3% 1/19 • Number of events 1 • baseline (day 0) to final (week 4)	0.00% 0/17 • baseline (day 0) to final (week 4)
Gastrointestinal disorders Constipation	5.3% 1/19 • Number of events 1 • baseline (day 0) to final (week 4)	0.00% 0/17 • baseline (day 0) to final (week 4)
Gastrointestinal disorders Nausea	5.3% 1/19 • Number of events 1 • baseline (day 0) to final (week 4)	0.00% 0/17 • baseline (day 0) to final (week 4)
General disorders Vein rupture	5.3% 1/19 • Number of events 1 • baseline (day 0) to final (week 4)	0.00% 0/17 • baseline (day 0) to final (week 4)
Cardiac disorders Supraventricular arrhythmia NOS	0.00% 0/19 • baseline (day 0) to final (week 4)	5.9% 1/17 • Number of events 1 • baseline (day 0) to final (week 4)

Additional Information

Dr. Martinez-Lemus

University of Missouri

Phone: 573-884-1222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place