Diabetes Mellitus, Type 2
Conditions
Keywords
endothelial dysfunction, vascular function
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
4 weeks of placebo supplements
DIETARY_SUPPLEMENTPhosphatidylserine
4 weeks of phosphatidylserine supplements
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blinded design with 34 subjects
Eligibility
Sex/Gender
ALL
Age
45 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women with a BMI of 25-39 kg/m2, who are 45-64 years of age at randomization. 2. T2D patients classified based on physician diagnosis. 3. No vulnerable populations (e.g., prisoners, pregnant, children) will be enrolled.
Exclusion criteria
1. Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke 2. History of chronic renal or hepatic disease 3. Active cancer 4. Autoimmune diseases 5. Immunosuppressant therapy 6. Hormone replacement therapy 7. Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women) 8. Current tobacco use 9. Pregnancy 10. Bodyweight change ≥5% within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin-stimulated Blood Flow | baseline and 4 weeks | Measure of blood flow during oral glucose tolerance test. Leg blood flow measures will be performed non-invasively via Ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Vascular Function | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 32 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 17 |
| other Total, other adverse events | 6 / 19 | 2 / 17 |
| serious Total, serious adverse events | 2 / 19 | 2 / 17 |
Outcome results
None listed