AgingNCT04112875
Effect of L-arginine on Microcirculation, Myogenesis and Angiogenesis Associated With Aging, Sarcopenia and Diabetes
A study testing L-arginine and Maltodextrin in people with Aging and Sarcopenia, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
This study aims was evaluated the effect of L-arginine on microcirculation, vasoreactivity / endothelial function and vascular smooth muscle of young and old women with Sarcopenia or Type 2 Diabetes Mellitus measured by Nailfold videocapillaroscopy and venous occlusion plethysmography before and after 14 days of… Read more about this study
- Who is it for?
- Ages 20 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Sarcopenia, Type 2 Diabetes
- What is being tested?
- L-arginine and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to Sep 2019
- 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 20 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- young women aged between 20 - 30 years, IMC < 24.9 kg/m2
- older women over 65 years healthy, BMI <35 kg/m2.
- Elderly women with or without a preexisting diagnosis of diabetes mellitus with fasting plasma glucose (FPG) > 100 mg/dL were classified into type 2 diabetes mellitus.
Who cannot join
- involved type 1 diabetes mellitus
- insulin use, cognitive impairment
- frailty
- disorders cardiometabolic
- liver and/or kidney dysfunction
- autoimmune diseases
Show all 9Show fewer
- smoking
- rigorous exercise
- uncontrolled hypertension with pressure level > 140/90 mmHg, with up to two antihypertensive drugs of different classes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of L-arginine Supplementation on Microcirculation, Endothelial Function and Vascular Smooth Muscle of Young, Elderly and Patients With Sarcopenia and Type 2 Diabetes Mellitus
This study aims was evaluated the effect of L-arginine on microcirculation, vasoreactivity / endothelial function and vascular smooth muscle of young and old women with Sarcopenia or Type 2 Diabetes Mellitus measured by Nailfold videocapillaroscopy and venous occlusion plethysmography before and after 14 days of consumption 5g oral L-arginine supplementation.
Read the detailed description
Aging causes responsible endothelial changes, in part by a decrease in the blood flow of the skeletal muscles of the elderly. Reduction of muscle mass / function (Sarcopenia) and Diabetes Mellitus are frequent pathologies in the elderly. L-Arginine is a semi-essential amino acid precursor to nitric oxide synthesis (NO), an important vasodilator and protector cardiovascular.
Seventy-five women were allocated into three groups: twenty-five healthy young (HY) recruited among University students, and fifty women elderly, this was stratified in twenty-five healthy elderly (HE) control and twenty-five with hyperglycemia (HG) elderly from the ambulatories of the Geriatric and Diabetology at the State University of Rio de Janeiro (UERJ) and private supplementary health program. To control group was considered absence cardiovascular risk factor except advanced age. Participants were subjected to screening phase before being eligible for the study by telephone, which comprised of individual clinical history. All subjects signed the written Informed Consent Form enclosed in the protocol approved by Ethics Committee from the State University of Rio de Janeiro according to Helsinki Declaration.
The subjects elected for research made 4 visits to the Biovasc laboratory for data collection. First day: the protocol was explained and agreement from the voluntary obtained, followed and anamnesis and physical exam that included measure at-rest blood pressure, weight and height. Moreover, women examined after 6 hours fasting the microcirculation function using nailfold vidiocapilaroscopy (NVC), followed of the measure of forearm blood flow (FBF) and vascular reactivity by venous occlusion plethysmography (VOP). Second day: Venous blood sample collection after 12 hours fasting. In sequence, they realized whole-body dual-energy X-ray absorptiometry (DXA) to calculate the body composition main measure lean and fat mass. After, was delivered a box with 14 sachets content 5g L-arginine supplementation, and it was recommended to ingest with water 30 minutes before breakfast during 14 days. Third day: Return after the supplementation to realize measurement weight, and exams NVC and VOP. Fourth day: blood sample were taken after 12 hours fasting under effect of the L-arginine.
- Conditions
- Aging, Sarcopenia, Type 2 Diabetes, Microcirculation
- Being tested
- L-arginine, Maltodextrin
- Keywords
- L-arginine, Asymmetric Dimethylarginine, Arginase, Sarcopenia, Myostatin, Follistatin, Type 2 diabetes mellitus, Vascular smooth muscle, endothelial function
- Medical subject headings
- Sarcopenia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginineDietary supplement
Handled powdered supplement to be mixed with water, has orange flavor for oral use.
MaltodextrinDietary supplement
hydrolysis of cornstarch or starch as a white powder to be mixed with water, has orange flavor for oral use.
| Study group | Role | What they receive |
|---|---|---|
| L-arginine | Active comparator | L-arginine supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days. Receives: Dietary Supplement: L-arginine |
| Maltodextrin | Placebo comparator | Maltodextrin supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Microcirculation
Assessing microvascular changes in the peripheral circulation by microcirculatory image recordings were used Nailfold vidiocapilaroscopy.
Measured: before and after 14 days of intervention
Changes in Endothelium-dependent and endothelium-independent vasodilation
Changes in vasodilatation by endothelial reactivity and smooth muscle responsiveness were assessed by Venous occlusion plethysmography
Measured: before and after 14 days of intervention
Secondary outcomes (3)
Change in metabolic markers
Metabolic markers associated with lipid profile (total cholesterol, triglycerides, Low Density Lipoproteins (HDLc) and High Density Lipoproteins (LDLc)); renal profile (urea and creatinine); Glycemic and insulin were analyzed to verify treatment response by comparing the results (mg/dL) before and after oral supplementation in the studied groups.
Measured: before and after 14 days of intervention
change in circulating muscle growth and degradation factors
Insulin-like growth factor-I (IGF-I) and follistatin (Fslt-I) growth-associated and (GDF-8 / Myostatin and interleukin 6 (IL-6)) degradation-associated were analyzed to verify response to treatment, comparing results (ng / ml) before and after oral supplementation in the study groups.
Measured: before and after 14 days of intervention
Body composition by DXA
The whole-body dual-energy X-ray absorptiometry (DXA) was used to measure appendicular skeletal muscle (ASM) composed lean body mass of arms and legs to calculated skeletal muscle mass index by following formula: ASM/height2.
Measured: before of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study startApr 2016
- Primary completionApr 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory for Clinical and Experimental Research on Vascular Biology
- Responsible party
- Principal investigator, Gerusa Maritimo da Costa, Rio de Janeiro State University
- Investigators
- Daniel A Bottino, PhD, Principal investigator, State University of Rio de JaneiroGerusa M Costa, MSc, Principal investigator, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112875
- Sponsor's protocol ID
- Arginine
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of L-arginine Supplementation on Microcirculation, Endothelial Function and Vascular Smooth Muscle of Young, Elderly and Patients With Sarcopenia and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04112875
- Acronym / sponsor ID
- Arginine
- Conditions
- Aging, Sarcopenia, Type 2 Diabetes, Microcirculation
- Keywords
- L-arginine, Asymmetric Dimethylarginine, Arginase, Sarcopenia, Myostatin, Follistatin, Type 2 diabetes mellitus, Vascular smooth muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Laboratory for Clinical and Experimental Research on Vascular Biology
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 2 Oct 2019 (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.
This study aims was evaluated the effect of L-arginine on microcirculation, vasoreactivity / endothelial function and vascular smooth muscle of young and old women with Sarcopenia or Type 2 Diabetes Mellitus measured by Nailfold videocapillaroscopy and venous occlusion plethysmography before and after 14 days of consumption 5g oral L-arginine supplementation.
Detailed description
Aging causes responsible endothelial changes, in part by a decrease in the blood flow of the skeletal muscles of the elderly. Reduction of muscle mass / function (Sarcopenia) and Diabetes Mellitus are frequent pathologies in the elderly. L-Arginine is a semi-essential amino acid precursor to nitric oxide synthesis (NO), an important vasodilator and protector cardiovascular.
Seventy-five women were allocated into three groups: twenty-five healthy young (HY) recruited among University students, and fifty women elderly, this was stratified in twenty-five healthy elderly (HE) control and twenty-five with hyperglycemia (HG) elderly from the ambulatories of the Geriatric and Diabetology at the State University of Rio de Janeiro (UERJ) and private supplementary health program. To control group was considered absence cardiovascular risk factor except advanced age. Participants were subjected to screening phase before being eligible for the study by telephone, which comprised of individual clinical history. All subjects signed the written Informed Consent Form enclosed in the protocol approved by Ethics Committee from the State University of Rio de Janeiro according to Helsinki Declaration.
The subjects elected for research made 4 visits to the Biovasc laboratory for data collection. First day: the protocol was explained and agreement from the voluntary obtained, followed and anamnesis and physical exam that included measure at-rest blood pressure, weight and height. Moreover, women examined after 6 hours fasting the microcirculation function using nailfold vidiocapilaroscopy (NVC), followed of the measure of forearm blood flow (FBF) and vascular reactivity by venous occlusion plethysmography (VOP). Second day: Venous blood sample collection after 12 hours fasting. In sequence, they realized whole-body dual-energy X-ray absorptiometry (DXA) to calculate the body composition main measure lean and fat mass. After, was delivered a box with 14 sachets content 5g L-arginine supplementation, and it was recommended to ingest with water 30 minutes before breakfast during 14 days. Third day: Return after the supplementation to realize measurement weight, and exams NVC and VOP. Fourth day: blood sample were taken after 12 hours fasting under effect of the L-arginine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-arginine | Active comparator | Dietary Supplement: L-arginineL-arginine supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days. |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- young women aged between 20 - 30 years, IMC < 24.9 kg/m2
- older women over 65 years healthy, BMI <35 kg/m2.
- Elderly women with or without a preexisting diagnosis of diabetes mellitus with fasting plasma glucose (FPG) > 100 mg/dL were classified into type 2 diabetes mellitus.
Key exclusion criteria (9 listed)
- involved type 1 diabetes mellitus
- insulin use, cognitive impairment
- frailty
- disorders cardiometabolic
- liver and/or kidney dysfunction
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-arginineHandled powdered supplement to be mixed with water, has orange flavor for oral use. | Dietary supplement | L-arginine |
| Maltodextrinhydrolysis of cornstarch or starch as a white powder to be mixed with water, has orange flavor for oral use. | Dietary supplement | Maltodextrin |
Primary outcome
Changes in Microcirculation
Time frame: before and after 14 days of intervention
Assessing microvascular changes in the peripheral circulation by microcirculatory image recordings were used Nailfold vidiocapilaroscopy.
Changes in Endothelium-dependent and endothelium-independent vasodilation
Time frame: before and after 14 days of intervention
Changes in vasodilatation by endothelial reactivity and smooth muscle responsiveness were assessed by Venous occlusion plethysmography
3 secondary outcomes
Change in metabolic markers
Time frame: before and after 14 days of intervention
change in circulating muscle growth and degradation factors
Time frame: before and after 14 days of intervention
Body composition by DXA
Time frame: before of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available.
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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.
Daniel A Bottino, PhD principal investigator
State University of Rio de Janeiro
Gerusa M Costa, MSc principal investigator
State University of Rio de Janeiro
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-arginine and Maltodextrin in people with Aging and Sarcopenia, run by Rio de Janeiro State University at 1 site in Brazil.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 2 Oct 2019. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Microcirculation (time frame: before and after 14 days of intervention). 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?
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 2 Oct 2019.