ADAM17 and Vascular Function in Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blinded design with 34 subjects

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Study participants will receive 4 weeks of supplementation with 900mg placebo supplements

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

4 weeks of placebo supplements

Phosphatidylserine Supplementation

Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements.

Group Type EXPERIMENTAL

Phosphatidylserine

Intervention Type DIETARY_SUPPLEMENT

4 weeks of phosphatidylserine supplements

Interventions

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Placebo

4 weeks of placebo supplements

Intervention Type DIETARY_SUPPLEMENT

Phosphatidylserine

4 weeks of phosphatidylserine supplements

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No