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The objective of this project is to determine the extent to which administration of the dietary supplement phosphatidylserine (PS), a competitive inhibitor of ADAM17 sheddase activity, effects vascular function and insulin-stimulated leg blood flow in subjects with T2D.
As part of a randomized (1:1, experimental/placebo), double-blinded parallel design, each of the 34 subjects will complete 4 weeks (+/-4 days) of supplementation with either 900mg of a PS supplement or placebo. Assessment visits (2) will occur pre-intervention and post-intervention and include: 24-hour ambulatory blood pressure measurement (ABPM), Vitals, DEXA scan for body composition, fasting blood work, carotid-femoral pulse wave velocity (cfPWV), brachial and femoral artery FMDs, Femoral blood flow imaging during passive leg movement (PLM), glycocalyx integrity assessment via Glycocheck, and an oral glucose tolerance test (OGTT) with blood flow measurements and beat-to-beat sphygmomanometry via Finometer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Study participants will receive 4 weeks of supplementation with 900mg placebo supplements |
|
| Phosphatidylserine Supplementation | Experimental | Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 4 weeks of placebo supplements |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insulin-stimulated Blood Flow | Measure of blood flow during oral glucose tolerance test. Leg blood flow measures will be performed non-invasively via Ultrasound. | baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Vascular Function | Flow mediated dilation (FMD) in arm and passive limb movement (PLM) in the leg. Blood flow measures will be performed non-invasively via Ultrasound. | Baseline and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri- NextGen Clinical Translational Science Unit | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Study participants will receive 4 weeks of supplementation with 900mg placebo supplements Placebo: 4 weeks of placebo supplements |
| FG001 | Phosphatidylserine Supplementation | Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements. Phosphatidylserine: 4 weeks of phosphatidylserine supplements |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Study participants will receive 4 weeks of supplementation with 900mg placebo supplements Placebo: 4 weeks of placebo supplements |
| BG001 | Phosphatidylserine Supplementation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Insulin-stimulated Blood Flow | Measure of blood flow during oral glucose tolerance test. Leg blood flow measures will be performed non-invasively via Ultrasound. | Posted | Mean | Standard Deviation | mL/min | baseline and 4 weeks |
|
baseline (day 0) to final (week 4)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Study participants will receive 4 weeks of supplementation with 900mg placebo supplements Placebo: 4 weeks of placebo supplements |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | Non-systematic Assessment | CTCAE v3.0, Hypertension, grade 1 or 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neuropathy | Nervous system disorders | CTCAE v3.0 | Non-systematic Assessment | Neuropathy-sensory, grade 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martinez-Lemus | University of Missouri | 573-884-1222 | martinezlemusl@umsystem.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2024 | Apr 2, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2024 | Apr 29, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2024 | Jul 14, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010718 | Phosphatidylserines |
| ID | Term |
|---|---|
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D005994 | Glycerophosphates |
| D010743 | Phospholipids |
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Randomized, double-blinded design with 34 subjects
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| Phosphatidylserine |
| Dietary Supplement |
4 weeks of phosphatidylserine supplements |
|
Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements.
Phosphatidylserine: 4 weeks of phosphatidylserine supplements
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percent Change in Vascular Function | Flow mediated dilation (FMD) in arm and passive limb movement (PLM) in the leg. Blood flow measures will be performed non-invasively via Ultrasound. | Posted | Mean | Standard Deviation | Percent Change in Vascular function | Baseline and 4 weeks |
|
|
|
| 0 |
| 19 |
| 2 |
| 19 |
| 6 |
| 19 |
| EG001 | Phosphatidylserine Supplementation | Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements. Phosphatidylserine: 4 weeks of phosphatidylserine supplements | 0 | 17 | 2 | 17 | 2 | 17 |
|
|
| Covid-19 Infection | General disorders | CTCAE v3.0 | Non-systematic Assessment | Constitutional Symptoms - Other (Covid-19 infection) grade 2 |
|
| Hyperglycemia | Endocrine disorders | CTCAE v3.0 | Non-systematic Assessment | Hyperglycemia, grade 2 |
|
| Hypersensitivity | Immune system disorders | CTCAE v3.0 | Non-systematic Assessment | Allergic reaction/ hypersensitivity, grade 1 |
|
| Constipation | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment | Constipation, grade 1 |
|
| Nausea | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment | Nausea, grade 1 |
|
| Vein rupture | General disorders | CTCAE v3.0 | Non-systematic Assessment | Vessel injury-vein-extremity-upper, grade 1 |
|
| Supraventricular arrhythmia NOS | Cardiac disorders | CTCAE v3.0 | Non-systematic Assessment | Supraventricular arrhythmia NOS, grade 1 |
|
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| D004700 | Endocrine System Diseases |
| D008563 |
| Membrane Lipids |
| D008055 | Lipids |