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L-Citrulline for Type 2 Diabetes

N/A
Recruiting
Led By Arturo Figueroa, Ph.D, MD
Research Sponsored by Texas Tech University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Treated with an oral hypoglycemic medication
A physician diagnosed type 2 diabetes at least 3 months ago
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial looks at if Citrulline supplements can improve blood flow in middle-aged and older adults with type 2 diabetes.

Who is the study for?
This trial is for middle-aged and older adults (40-75 years old) with type 2 diabetes, a BMI under 40 kg/m2, controlled blood pressure, and on oral diabetes medication. Participants should be sedentary, not currently in other interventions, and non-smokers without recent medication changes.Check my eligibility
What is being tested?
The study tests if taking L-Citrulline supplements for four weeks improves large and small blood vessel function during high blood sugar episodes in people with type 2 diabetes compared to a placebo.See study design
What are the potential side effects?
L-Citrulline may cause digestive discomfort or changes in blood pressure. Since it affects vascular function, there might also be potential side effects related to the cardiovascular system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am taking oral medication for diabetes.
Select...
I was diagnosed with type 2 diabetes over 3 months ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in blood glucose levels during acute hyperglycemia
Change in blood glucose levels in the fasted condition
Change in blood pressure during acute hyperglycemia
+11 more
Secondary outcome measures
Change in 24-hour ambulatory blood pressure monitoring
Change in body composition
Change in insulin levels
+3 more

Side effects data

From 2019 Phase 3 trial • 189 Patients • NCT02891837
19%
Pyrexia
16%
Pain
14%
Restlessness
12%
Hypokalaemia
12%
Tachycardia
12%
Pleural effusion
12%
Hypertension
11%
Constipation
7%
Atelectasis
7%
Haemoglobin decreased
7%
Hypocalcaemia
6%
Hypotension
6%
Oligurea
6%
Vomiting
6%
Electrolyte imbalance
6%
Stridor
6%
Pulmonary oedema
5%
Chylothorax
5%
Tachypnoea
4%
Coagulation time prolonged
4%
C-reactive protein increased
4%
Metabolic acidosis
4%
Pulmonary congestion
4%
Anaemia
4%
Cough
4%
Diarrhoea
3%
Sinus bradycardia
3%
Blood creatine phosphokinase increased
3%
Blood lactate dehydrogenase increased
3%
Leukopenia
3%
Atrioventricular block complete
3%
Cardiac output decreased
2%
Thrombocytopenia
2%
Oedema peripheral
2%
Arrhythmia
2%
Cardiac failure
2%
Adrenal insufficiency
2%
Hypoalbuminaemia
2%
Aortic valve incompetence
2%
Post procedural haemorrhage
2%
Haematocrit decreased
1%
Aspartate aminotransferase increased
1%
Staphylococcal infection
1%
Nausea
1%
Cardiac tamponade
1%
Ventricular fibrillation
1%
Blood lactic acid increased
1%
Ventricular tachycardia
1%
Junctional ectopic tachycardia
1%
Swallow study abnormal
1%
Coagulopathy
1%
Leukocytosis
1%
Atrioventricular block
1%
Supraventricular extrasystoles
1%
Hypothermia
1%
Oedema
1%
Peripheral swelling
1%
Secretion discharge
1%
Respiratory arrest
1%
Hypomagnesaemia
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
L-citrulline - All Patients
L-citrulline - All Patients on Mechanical Ventilation for ≤48 Hours
L-citrulline - US Patients on Mechanical Ventilation for >48 Hours
Placebo - All Patients
L-citrulline - US Patients on Mechanical Ventilation for ≤48 Hours
L-citrulline - All Patients on Mechanical Ventilation for >48 Hours
Placebo - All Patients on Mechanical Ventilation for ≤48 Hours
Placebo - US Patients on Mechanical Ventilation for ≤48 Hours
Placebo - All Patients on Mechanical Ventilation for >48 Hours
Placebo - US Patients on Mechanical Ventilation for >48 Hours

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: L-citrullineExperimental Treatment1 Intervention
6 grams/day
Group II: PlaceboPlacebo Group1 Intervention
Microcrystalline cellulose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-citrulline
2010
Completed Phase 3
~530

Find a Location

Who is running the clinical trial?

Texas Tech UniversityLead Sponsor
81 Previous Clinical Trials
9,128 Total Patients Enrolled
Arturo Figueroa, Ph.D, MDPrincipal InvestigatorTexas Tech University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age requirement for this clinical research extend beyond those under fifty?

"Patients aged between 40 and 75 are welcome to participate in this experiment."

Answered by AI

Could I potentially qualify to be a partaker in this clinical experiment?

"Prerequisites for participating in this clinical trial include a diagnosis of type 2 diabetes and being between 40 to 75 years old. The study is looking for approximately 36 individuals who meet these requirements."

Answered by AI

How many volunteers have joined the experiment?

"Indeed, clinicaltrials.gov's information confirms that this medical trial is presently looking for enrollees; it was initially published on May 1st 2023 and updated most recently on August 24th of the same year. 36 people from a singular site are needed to be included in the study."

Answered by AI

What are the primary objectives of this clinical experiment?

"This 4-week trial seeks to assess the influence of acute hyperglycemia on macrovascular endothelial function. Secondary objectives include assessing alterations in muscle strength, insulin levels, and serum arginine concentrations via maximal handgrip dynamometer tests, 10RM exercises, and laboratory analyses respectively."

Answered by AI

Are researchers actively seeking out new participants for this investigation?

"The posted information on clinicaltrials.gov reports that the trial is currently seeking participants and was initially published on May 1, 2023 with a recent update of August 24th, 2023."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effect of 4 Weeks of L-Citrulline Supplementation on Macro- and Microvascular Function in Type 2 Diabetes
Arturo Figueroa 2023. "The Effect of 4 Weeks of L-Citrulline Supplementation on Macro- and Microvascular Function in Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06016478.
~5 spots leftby Jul 2024
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