Type 2 Diabetes MellitusNCT03358264
Effect of L-Citrulline Supplementation on Arginase Activity and Vascular Function in Diabetes
A study testing L-citrulline in people with Type 2 Diabetes Mellitus, run by University of Jordan at 1 site in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- L-citrulline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes Diabetic state: HbA1c>6
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
The University of Jordan
Amman, 11942
Alia Shatanawi, PhD, DDS, +96265355000 ext. 23458, a.shatanawi@ju.edu.jo
Munir N Gharaibeh, PhD, MD, +96265355000 ext. 23456, mgharaib@ju.edu.jo
About this study
Official title: Effect of L-Citrulline Supplementation on Arginase Activity and Vascular Function in Type II Diabetes Mellitus
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- L-citrulline
- Keywords
- Vascular dysfunction, L-citrulline, arginase
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-citrullineDietary supplement
Amino acid supplement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: L-citrulline |
What is being measured
The primary outcome is the main question the study is designed to answer.
arginase activity
Levels of arginase activity enzyme will be measured in plasma in subjects before and after l-citrulline supplementation
Measured: 1 month
Vascular function
forearm vascular function will be assessed by flow mediated dilation of brachial blood vessels before and after L-citrulline supplementation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alia Shatanawi, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358264
- Sponsor's protocol ID
- Pharmacology-Medicine-UJ
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shatanawi A, Momani, MS. Plasma arginase activity is elevated in type 2 diabetic patients. Biomedical Research-India 28(9): 4102-4106, 2017
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of L-Citrulline Supplementation on Arginase Activity and Vascular Function in Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03358264
- Acronym / sponsor ID
- Pharmacology-Medicine-UJ
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Vascular dysfunction, L-citrulline, arginase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic patients | Experimental | Dietary Supplement: L-citrullineL-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 |
| Healthy volunteers | Experimental | Dietary Supplement: L-citrullineL-citrulline at a dose of 2000 mg per day for a period of 1 month will be administered to non-diabetic healthy volunteers |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes Diabetic state: HbA1c>6
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-citrullineAmino acid supplement | Dietary supplement | Healthy volunteers, Type 2 diabetic patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- BackgroundShatanawi A, Momani, MS. Plasma arginase activity is elevated in type 2 diabetic patients. Biomedical Research-India 28(9): 4102-4106, 2017
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-citrulline in people with Type 2 Diabetes Mellitus, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alia Shatanawi, PhD, DDS (+96265355000 ext. 23458, a.shatanawi@ju.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arginase activity (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03358264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.