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Effect of L-Citrulline Supplementation on Arginase Activity and Vascular Function in Diabetes

This study is currently recruiting participants.
Verified November 2017 by Alia Shatanawi, University of Jordan
Sponsor:
ClinicalTrials.gov Identifier:
NCT03358264
First Posted: November 30, 2017
Last Update Posted: November 30, 2017
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.
Information provided by (Responsible Party):
Alia Shatanawi, University of Jordan
  Purpose
Arginase has recently been implicated in an array of vascular conditions including atherosclerosis , hypertension and vascular complication of diabetes. In this study we will determine of L-citrulline; a natural amino acid that is known to have inhibitory effects on arginase activity, on vascular function in type 2 diabetic patients.

Condition Intervention
Type 2 Diabetes Mellitus Dietary Supplement: L-citrulline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of L-Citrulline Supplementation on Arginase Activity and Vascular Function in Type II Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Alia Shatanawi, University of Jordan:

Primary Outcome Measures:
  • arginase activity [ Time Frame: 1 month ]
    Levels of arginase activity enzyme will be measured in plasma in subjects before and after l-citrulline supplementation

  • Vascular function [ Time Frame: 1 month ]
    forearm vascular function will be assessed by flow mediated dilation of brachial blood vessels before and after L-citrulline supplementation


Estimated Enrollment: 50
Actual Study Start Date: January 1, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Type 2 diabetic patients
L-citrulline at a dose of 2000 mg per day for a period of 1 month will be administered to type 2 diabetic patients with HbA1c>6
Dietary Supplement: L-citrulline
Amino acid supplement
Experimental: Healthy volunteers
L-citrulline at a dose of 2000 mg per day for a period of 1 month will be administered to non-diabetic healthy volunteers
Dietary Supplement: L-citrulline
Amino acid supplement

Detailed Description:
Vascular dysfunction is a major cause of morbidity and mortality in diabetic patients. The pathological process is characterized by impaired endothelial cell production of the vasodilator and antiplatelet adhesion factor nitric oxide (NO) and/or decreased NO bioavailability. NO is a major regulator of vascular tone and integrity. In endothelial cells, NO is produced by activity of endothelial NO synthase (eNOS) on its substrate L-arginine. Reduced availability of L-arginine to eNOS has been implicated in vascular dysfunction in diabetes and a variety of other disease conditions. Arginase, which metabolizes L-arginine to urea and ornithine, competes directly with NOS for L-arginine. Hence increases in arginase activity can decrease tissue and cellular arginine levels, reducing its availability to eNOS and decreasing No production. During diabetes, elevated levels of arginase can compete with NOS for available arginine thus reducing vascular NO. We have recently shown that arginase activity is elevated in diabetes. In this proposal we implement a method of flow mediate dilation (FMD) to assess vascular function in diabetic patients. We will study the relation of our vascular function findings with arginase activity levels. We propose that arginase activity measurements could be novel marker of vascular dysfunction in diabetes. The effect of the natural amino acid supplements (L-citrulline) on levels of arginase activity in diabetic patients and vascular function will also be studied.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Type 2 diabetes Diabetic state: HbA1c>6

Exclusion Criteria:

  Contacts and Locations
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): NCT03358264


Contacts
Contact: Alia Shatanawi, PhD, DDS +96265355000 ext 23458 a.shatanawi@ju.edu.jo
Contact: Munir N Gharaibeh, PhD, MD 96265355000 ext 23456 mgharaib@ju.edu.jo

Locations
Jordan
The University of Jordan Recruiting
Amman, Jordan, 11942
Contact: Alia Shatanawi, PhD, DDS    +96265355000 ext 23458    a.shatanawi@ju.edu.jo   
Contact: Munir N Gharaibeh, PhD, MD    +96265355000 ext 23456    mgharaib@ju.edu.jo   
Sub-Investigator: Munther S Momani, MD         
Principal Investigator: Alia Shatanawi, PhD, DDS         
Sponsors and Collaborators
University of Jordan
  More Information

Publications:
Shatanawi A, Momani, MS. Plasma arginase activity is elevated in type 2 diabetic patients. Biomedical Research-India 28(9): 4102-4106, 2017

Responsible Party: Alia Shatanawi, Associate Professor, University of Jordan
ClinicalTrials.gov Identifier: NCT03358264     History of Changes
Other Study ID Numbers: Pharmacology-Medicine-UJ
First Submitted: November 26, 2017
First Posted: November 30, 2017
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alia Shatanawi, University of Jordan:
Vascular dysfunction, L-citrulline, arginase

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases