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Effect of L-arginine on Microcirculation, Myogenesis and Angiogenesis Associated With Aging, Sarcopenia and Diabetes

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ClinicalTrials.gov Identifier: NCT04112875
Recruitment Status : Completed
First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
Laboratory for Clinical and Experimental Research on Vascular Biology
Information provided by (Responsible Party):
Gerusa Maritimo da Costa, Rio de Janeiro State University

Brief 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 consumption 5g oral L-arginine supplementation.

Condition or disease Intervention/treatment Phase
Aging Sarcopenia Type 2 Diabetes Microcirculation Dietary Supplement: L-arginine Dietary Supplement: Maltodextrin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: L-arginine
L-arginine supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.
Dietary Supplement: L-arginine
Handled powdered supplement to be mixed with water, has orange flavor for oral use.

Placebo Comparator: Maltodextrin
Maltodextrin supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.
Dietary Supplement: Maltodextrin
hydrolysis of cornstarch or starch as a white powder to be mixed with water, has orange flavor for oral use.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Change in metabolic markers [ Time Frame: before and after 14 days of intervention ]
    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.

  2. change in circulating muscle growth and degradation factors [ Time Frame: before and after 14 days of intervention ]
    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.

  3. Body composition by DXA [ Time Frame: before of intervention ]
    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.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • involved type 1 diabetes mellitus
  • insulin use, cognitive impairment
  • frailty
  • disorders cardiometabolic
  • liver and/or kidney dysfunction
  • autoimmune diseases
  • smoking
  • rigorous exercise
  • uncontrolled hypertension with pressure level > 140/90 mmHg, with up to two antihypertensive drugs of different classes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112875


Locations
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Brazil
State University of Rio de Janeiro
Rio de Janeiro, Brazil, 20550900
Sponsors and Collaborators
Rio de Janeiro State University
Laboratory for Clinical and Experimental Research on Vascular Biology
Investigators
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Principal Investigator: Daniel A Bottino, PhD State University of Rio de Janeiro
Principal Investigator: Gerusa M Costa, MSc State University of Rio de Janeiro

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Responsible Party: Gerusa Maritimo da Costa, Principal Investigator, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT04112875     History of Changes
Other Study ID Numbers: Arginine
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gerusa Maritimo da Costa, Rio de Janeiro State University:
L-arginine
Asymmetric Dimethylarginine
Arginase
Sarcopenia
Myostatin
Follistatin
Type 2 diabetes mellitus
Vascular smooth muscle
endothelial function
Additional relevant MeSH terms:
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Sarcopenia
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms