- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06016478
The Effect of 4 Weeks of L-Citrulline Supplementation on Macro- and Microvascular Function in Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Using a double-blind, randomized, placebo-controlled, and cross-over design, middle-aged and older adults with type 2 diabetes will be randomized to receive either CIT supplementation (6g/day) or placebo (Microcrystalline Cellulose, 6g/day) for 4 weeks.
There will be a total of 5 laboratory visits. Visit 1 (screening visit) will take approximately 1 hour and 30 minutes, visit 2 will take approximately 2 hours and 30 minutes, and visits 3-5 will be approximately 3 hours each.
Visit 1 will measure blood pressure, blood glucose and lipid levels, anthropometry, body composition, and muscle strengths. Visits 2-5 will assess vascular function and glucose control during fasted and acute hyperglycemia conditions induced by 75g of glucose ingestion.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arturo Figueroa, Ph.D, MD
- Phone Number: 806-834-5587
- Email: arturo.figueroa@ttu.edu
Study Locations
-
-
Texas
-
Lubbock, Texas, United States, 79409
- Recruiting
- TTU Kinesiology and Sport Management Building
-
Contact:
- Arturo Figueroa, M.D., Ph.D.
- Phone Number: 806-834-5587
- Email: arturo.figueroa@ttu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Middle-aged and older women and men between 40-75 years old
- A physician diagnosed type 2 diabetes at least 3 months ago
- Treated with an oral hypoglycemic medication
- Body mass index < 40 kg/m2
- Systolic blood pressure < 160 mmHg
- Sedentary (defined as < 120 min/week of exercise)
- Not currently participating in exercise or dietary interventions for at least 2 months prior the present study and willing to abstain from participating in those strategies during the duration of this study.
Exclusion Criteria:
- < 40 years of age and > 65 years of age
- Use of medications and/or any supplements that may affect outcome variables (such as arginine- or citrulline-containing supplements, nitrates, and nitroglycerin)
- Body mass index ≥ 40 kg/m2
- Systolic blood pressure ≥ 160 mmHg
- Recent changes in medications within 3 months
- Current smoking any tobacco use
- Type 1 diabetes, severe cardiovascular/renal/pulmonary diseases
- More than 7 alcoholic drinks/week of consumption
- Premenopausal women with an irregular menstrual cycle (oligomenorrhea) or pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Microcrystalline cellulose
|
4 weeks of microcrystalline cellulose in 8 capsules.
Supplementation will be ingested daily, half of the doses in the morning and half at night.
|
Experimental: L-citrulline
6 grams/day
|
4 weeks of L-citrulline (6 g/day) in 8 capsules.
Supplementation will be ingested daily, half of the doses in the morning and half at night.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in macrovascular endothelial function in the fasted condition
Time Frame: 4 weeks
|
Macrovascular endothelial function will be measured using brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in macrovascular endothelial function during acute hyperglycemia
Time Frame: 4 weeks
|
Macrovascular endothelial function will be measured using brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in microvascular endothelial function in the fasted condition
Time Frame: 4 weeks
|
Microvascular endothelial function will be assessed using peripheral arterial tonometry (EndoPAT device) during reactive hyperemia at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in microvascular endothelial function in the fasted condition
Time Frame: 4 weeks
|
Microvascular endothelial function will be assessed using forearm muscle oxygenation (near-infrared spectroscopy) during reactive hyperemia at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in microvascular endothelial function during acute hyperglycemia
Time Frame: 4 weeks
|
Microvascular endothelial function will be assessed using forearm muscle oxygenation (near-infrared spectroscopy) during reactive hyperemia at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in blood glucose levels in the fasted condition
Time Frame: 4 weeks
|
Blood glucose levels will be measured by finger prick at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in blood glucose levels during acute hyperglycemia
Time Frame: 4 weeks
|
Blood glucose levels will be measured by finger prick at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in central and peripheral arterial stiffness in the fasted condition
Time Frame: 4 weeks
|
Arterial stiffness will be assessed using the central (carotid-femoral) and peripheral (femoral-ankle) pulse wave velocity at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in central and peripheral arterial stiffness during acute hyperglycemia
Time Frame: 4 weeks
|
Arterial stiffness will be assessed using the central (carotid-femoral) and peripheral (femoral-ankle) pulse wave velocity at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in blood pressure in the fasted condition
Time Frame: 4 weeks
|
Brachial and aortic blood pressure will be measured using an automated sphygmomanometry arm cuff (SphygmoCor XCEL).
Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Finometer).
Blood pressure will be measured at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in blood pressure during acute hyperglycemia
Time Frame: 4 weeks
|
Brachial and aortic blood pressure will be measured using an automated sphygmomanometry arm cuff (SphygmoCor XCEL).
Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Finometer).
Blood pressure will be measured at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in stroke volume in the fasted condition
Time Frame: 4 weeks
|
Stroke volume will be measured using impedance cardiography (PhysioFlow) at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in stroke volume during acute hyperglycemia
Time Frame: 4 weeks
|
Stroke volume will be measured using impedance cardiography (PhysioFlow) at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in total peripheral resistance in the fasted condition
Time Frame: 4 weeks
|
Total peripheral resistance will be measured using impedance cardiography (PhysioFlow) at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in total peripheral resistance during acute hyperglycemia
Time Frame: 4 weeks
|
Total peripheral resistance will be measured using impedance cardiography (PhysioFlow) at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body composition
Time Frame: 4 weeks
|
Body composition (fat and lean mass) will be measured at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in muscle strength
Time Frame: 4 weeks
|
Maximal handgrip strength will be measured using handgrip dynamometer.
Leg extension and plantar flexion strength will be measured using the 10RM test at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in insulin levels
Time Frame: 4 weeks
|
Serum insulin levels will be tested at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in serum arginine levels
Time Frame: 4 weeks
|
Serum arginine levels will tested at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in serum arginase activity levels
Time Frame: 4 weeks
|
Serum arginase activity levels will tested at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Change in 24-hour ambulatory blood pressure monitoring
Time Frame: 4 weeks
|
Ambulatory blood pressure will be obtained using a monitor during daytime and nighttime on two separate days at baseline and after 4 weeks of supplementation.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arturo Figueroa, Ph.D, MD, Texas Tech University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2022-1056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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