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ADAM17 and Vascular Function in Diabetes (ADAM17)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Phosphatidylserine
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring endothelial dysfunction, vascular function

Eligibility Criteria

45 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri- NextGen Clinical Translational Science UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Phosphatidylserine Supplementation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 8, 2020
Last Updated
April 4, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04557228
Brief Title
ADAM17 and Vascular Function in Diabetes
Acronym
ADAM17
Official Title
Targeting ADAM17 Activity for Correction of Vascular Insulin Resistance in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 (2:1, experimental/placebo), double-blinded parallel design, each of the 34 subjects will complete either 4 weeks of supplementation with 900mg of PS 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
endothelial dysfunction, vascular function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blinded design with 34 subjects
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Study participants will receive 4 weeks of supplementation with 900mg placebo supplements
Arm Title
Phosphatidylserine Supplementation
Arm Type
Experimental
Arm Description
Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
4 weeks of placebo supplements
Intervention Type
Dietary Supplement
Intervention Name(s)
Phosphatidylserine
Intervention Description
4 weeks of 900mg phosphatidylserine supplements
Primary Outcome Measure Information:
Title
Change in Insulin-stimulated blood flow
Description
Measure of blood flow during oral glucose tolerance test. Leg blood flow measures will be performed non-invasively via Ultrasound.
Time Frame
baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in Vascular function
Description
Flow mediated dilation (FMD) in arm and passive limb movement (PLM) in the leg. Blood flow measures will be performed non-invasively via Ultrasound.
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women with a BMI of 25-39 kg/m2, who are 45-64 years of age at randomization. T2D patients classified based on physician diagnosis. No vulnerable populations (e.g., prisoners, pregnant, children) will be enrolled. Exclusion Criteria: Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke History of chronic renal or hepatic disease Active cancer Autoimmune diseases Immunosuppressant therapy Hormone replacement therapy Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women) Current tobacco use Pregnancy Bodyweight change ≥5% within the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Martinez-Lemus, PhD
Phone
(573) 882-3244
Email
martinezlemusl@missouri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jaume Padilla, PhD
Phone
(573) 882-7056
Email
padillaja@missouri.edu
Facility Information:
Facility Name
University of Missouri- NextGen Clinical Translational Science Unit
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis A Martinez-Lemus, PhD
Phone
573-882-3244
Email
martinezlemusl@missouri.edu
First Name & Middle Initial & Last Name & Degree
Jaume Padilla, PhD
Phone
(573) 882-7056
Email
padillaja@missouri.edu
First Name & Middle Initial & Last Name & Degree
Luis A Martinez-Lemus, PhD
First Name & Middle Initial & Last Name & Degree
Jaume Padilla, PhD
First Name & Middle Initial & Last Name & Degree
Camila M Manrique, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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ADAM17 and Vascular Function in Diabetes

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