Clinical trial NCT04112875: 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
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Sarcopenia
Type 2 Diabetes
Microcirculation
Keywords: L-arginine
Asymmetric Dimethylarginine
Arginase
Sarcopenia
Myostatin
Follistatin
Type 2 diabetes mellitus
Vascular smooth muscle
endothelial function
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Laboratory for Clinical and Experimental Research on Vascular Biology
First posted: 2019-10-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in Microcirculation
timeFrame: before and after 14 days of intervention
measure: Changes in Endothelium-dependent and endothelium-independent vasodilation
timeFrame: before and after 14 days of intervention
Secondary outcomes:
measure: Change in metabolic markers
timeFrame: before and after 14 days of intervention
measure: change in circulating muscle growth and degradation factors
timeFrame: before and after 14 days of intervention
measure: Body composition by DXA
timeFrame: before of intervention
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: State University of Rio de Janeiro
Study officials:
affiliation: State University of Rio de Janeiro
name: Daniel A Bottino, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of Rio de Janeiro
name: Gerusa M Costa, MSc
role: PRINCIPAL_INVESTIGATOR
References: