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

NCT ID: NCT03358264

Last Updated: 2017-11-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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Vascular dysfunction, L-citrulline, arginase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

L-citrulline

Intervention Type DIETARY_SUPPLEMENT

Amino acid supplement

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

Group Type EXPERIMENTAL

L-citrulline

Intervention Type DIETARY_SUPPLEMENT

Amino acid supplement

Interventions

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L-citrulline

Amino acid supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Type 2 diabetes Diabetic state: HbA1c\>6

Exclusion Criteria

\-
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Alia Shatanawi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Jordan

Amman, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Alia Shatanawi, PhD, DDS

Role: CONTACT

Phone: +96265355000

Email: [email protected]

Munir N Gharaibeh, PhD, MD

Role: CONTACT

Phone: 96265355000

Email: [email protected]

Facility Contacts

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Alia Shatanawi, PhD, DDS

Role: primary

Munir N Gharaibeh, PhD, MD

Role: backup

References

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

Reference Type BACKGROUND

Other Identifiers

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Pharmacology-Medicine-UJ

Identifier Type: -

Identifier Source: org_study_id