Effect of L-arginine on Microcirculation, Myogenesis and Angiogenesis Associated With Aging, Sarcopenia and Diabetes
Primary Purpose
Aging, Sarcopenia, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
L-arginine
Maltodextrin
Sponsored by
About this trial
This is an interventional treatment trial for Aging focused on measuring L-arginine, Asymmetric Dimethylarginine, Arginase, Sarcopenia, Myostatin, Follistatin, Type 2 diabetes mellitus, Vascular smooth muscle, endothelial function
Eligibility 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.
Sites / Locations
- State University of Rio de Janeiro
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
L-arginine
Maltodextrin
Arm Description
L-arginine supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.
Maltodextrin supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.
Outcomes
Primary Outcome Measures
Changes in Microcirculation
Assessing microvascular changes in the peripheral circulation by microcirculatory image recordings were used Nailfold vidiocapilaroscopy.
Changes in Endothelium-dependent and endothelium-independent vasodilation
Changes in vasodilatation by endothelial reactivity and smooth muscle responsiveness were assessed by Venous occlusion plethysmography
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04112875
First Posted
September 25, 2019
Last Updated
October 1, 2019
Sponsor
Rio de Janeiro State University
Collaborators
Laboratory for Clinical and Experimental Research on Vascular Biology
1. Study Identification
Unique Protocol Identification Number
NCT04112875
Brief Title
Effect of L-arginine on Microcirculation, Myogenesis and Angiogenesis Associated With Aging, Sarcopenia and Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rio de Janeiro State University
Collaborators
Laboratory for Clinical and Experimental Research on Vascular Biology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Sarcopenia, Type 2 Diabetes, Microcirculation
Keywords
L-arginine, Asymmetric Dimethylarginine, Arginase, Sarcopenia, Myostatin, Follistatin, Type 2 diabetes mellitus, Vascular smooth muscle, endothelial function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-arginine
Arm Type
Active Comparator
Arm Description
L-arginine supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Maltodextrin supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
L-arginine
Intervention Description
Handled powdered supplement to be mixed with water, has orange flavor for oral use.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
hydrolysis of cornstarch or starch as a white powder to be mixed with water, has orange flavor for oral use.
Primary Outcome Measure Information:
Title
Changes in Microcirculation
Description
Assessing microvascular changes in the peripheral circulation by microcirculatory image recordings were used Nailfold vidiocapilaroscopy.
Time Frame
before and after 14 days of intervention
Title
Changes in Endothelium-dependent and endothelium-independent vasodilation
Description
Changes in vasodilatation by endothelial reactivity and smooth muscle responsiveness were assessed by Venous occlusion plethysmography
Time Frame
before and after 14 days of intervention
Secondary Outcome Measure Information:
Title
Change in metabolic markers
Description
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.
Time Frame
before and after 14 days of intervention
Title
change in circulating muscle growth and degradation factors
Description
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.
Time Frame
before and after 14 days of intervention
Title
Body composition by DXA
Description
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.
Time Frame
before of intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel A Bottino, PhD
Organizational Affiliation
State University of Rio de Janeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerusa M Costa, MSc
Organizational Affiliation
State University of Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University of Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
20550900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.
Learn more about this trial
Effect of L-arginine on Microcirculation, Myogenesis and Angiogenesis Associated With Aging, Sarcopenia and Diabetes
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