NCT03358264

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

November 26, 2017

Last Update Submit

November 26, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

Vascular dysfunction, L-citrulline, arginase

Outcome Measures

Primary Outcomes (2)

  • arginase activity

    Levels of arginase activity enzyme will be measured in plasma in subjects before and after l-citrulline supplementation

    1 month

  • Vascular function

    forearm vascular function will be assessed by flow mediated dilation of brachial blood vessels before and after L-citrulline supplementation

    1 month

Study Arms (2)

Type 2 diabetic patients

EXPERIMENTAL

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

Healthy volunteers

EXPERIMENTAL

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

Interventions

L-citrullineDIETARY_SUPPLEMENT

Amino acid supplement

Healthy volunteersType 2 diabetic patients

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes Diabetic state: HbA1c\>6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Jordan

Amman, 11942, Jordan

RECRUITING

Related Publications (1)

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

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Citrulline

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, DiaminoAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

Alia Shatanawi, PhD, DDS

CONTACT

+96265355000a.shatanawi@ju.edu.jo

Munir N Gharaibeh, PhD, MD

CONTACT

96265355000mgharaib@ju.edu.jo

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 26, 2017

First Posted

November 30, 2017

Study Start

January 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 30, 2017

Record last verified: 2017-11

Locations

JO(1)