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ADAM17 and Vascular Function in Diabetes (ADAM17)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04557228
Recruitment Status : Not yet recruiting
First Posted : September 21, 2020
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Luis Martinez-Lemus, DVM, PhD, University of Missouri-Columbia

Study Description
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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, improves vascular function and insulin-stimulated leg blood flow in subjects with type 2 diabetes (T2D).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Dietary Supplement: Placebo Dietary Supplement: Phosphatidylserine Not Applicable

Detailed Description:
As part of a randomized, double-blinded crossover design, each of the 34 subjects will complete 4 weeks of supplementation with 400mg of PS and 4 weeks of placebo. Subjects will have a 4-week washout period between regimens. Assessment visits (2) will occur after each of the 4-week dosing schemes and include: Vitals, DEXA scan for body composition, fasting blood work, brachial artery flow-mediated dilation (FMD) with near infrared spectroscopy (NIRS), skeletal muscle biopsy, glycocalyx integrity assessment via Glycocheck, and 1-hour insulin clamp procedure with blood flow measurements.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, double-blinded crossover design with 34 subjects
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Targeting ADAM17 Activity for Correction of Vascular Insulin Resistance in Type 2 Diabetes
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : November 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Study participants will receive 4 weeks of supplementation with 400mg placebo supplements
 Dietary Supplement: Placebo
4 weeks of placebo supplements
Experimental: Phosphatidylserine Supplementation
Study participants will receive 4 weeks of supplementation with 400mg phosphatidylserine supplements.
 Dietary Supplement: Phosphatidylserine
4 weeks of 400mg phosphatidylserine supplements


Outcome Measures
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Primary Outcome Measures :
  1. Change in Insulin-stimulated blood flow [ Time Frame: week 4 and week 12 ]
    Measure of blood flow during insulin clamp. Leg blood flow measures will be performed non-invasively via Ultrasound.


Secondary Outcome Measures :
  1. Change in Vascular function [ Time Frame: week 4 and week 12 ]
    Flow mediated dilation (FMD) in arm. Brachial artery FMD measures will be performed non-invasively via Ultrasound.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557228


Contacts
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Contact: Luis Martinez-Lemus, PhD (573) 882-3244 martinezlemusl@missouri.edu
Contact: Jaume Padilla, PhD (573) 882-7056 padillaja@missouri.edu

Locations
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United States, Missouri
University of Missouri- Dalton Cardiovascular Research Center
Columbia, Missouri, United States, 65211
Contact: Luis A Martinez-Lemus, PhD    573-882-3244    martinezlemusl@missouri.edu   
Contact: Jaume Padilla, PhD    (573) 882-7056    padillaja@missouri.edu   
Principal Investigator: Luis A Martinez-Lemus, PhD         
Sub-Investigator: Jaume Padilla, PhD         
Sub-Investigator: Camila M Manrique, MD         
Sponsors and Collaborators
University of Missouri-Columbia
More Information
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Responsible Party: Luis Martinez-Lemus, DVM, PhD, Professor in Medical Pharmacology Physiology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04557228    
Other Study ID Numbers: 2025921
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luis Martinez-Lemus, DVM, PhD, University of Missouri-Columbia:
endothelial dysfunction
insulin-stimulated blood flow
vascular function
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases