AzTrials
AzTrials

SarcopeniaNCT04309201

Insulin Resistance, Sarcopenia and Plasma BAIBA Levels

An observational study of Sarcopenia and Insulin Resistance, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Insulin resistance (IR) is an early metabolic alteration in chronic kidney disease (CKD) patients, becoming almost universal in those who reach the end stage of kidney failure. The skeletal muscle represents the primary site of IR in CKD, and alterations at sites beyond the insulin receptor are recognized as the main… Read more about this study

Who is it for?
Ages 20 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Insulin Resistance
How many people
150 participants
Where
1 siteTaiwan
Study dates
10 Mar 2020to 31 Dec 2020
Phase
Observational
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 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: hemodialysis (HD) patients

Who may be able to join

  • Received stable hemodialysis at least 3 months

Who cannot join

  • cancer
  • heart failure
  • severe liver disease
  • chronic infection such diabetic foot

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Tungs' Taichung MetroHarbour Hospital

    Taichung

Other trials in Taiwan

About this study

Official title: Relationship With Muscle Wasting and Insulin Resistance in a Group of Non-diabetic Hemodialysis Patients.

Insulin resistance (IR) is an early metabolic alteration in chronic kidney disease (CKD) patients, becoming almost universal in those who reach the end stage of kidney failure. The skeletal muscle represents the primary site of IR in CKD, and alterations at sites beyond the insulin receptor are recognized as the main defect underlying IR in this condition. The etiology of IR in CKD is multifactorial in nature and may be secondary to disturbances that are prominent in renal diseases, including physical inactivity, chronic inflammation, oxidative stress, vitamin D deficiency, metabolic acidosis, anemia, adipokine derangement, and altered gut microbiome.

IR has been solidly associated with intermediate mechanisms leading to cardiovascular (CV) disease in CKD including left ventricular hypertrophy, vascular dysfunction, and atherosclerosis. Recent studies have identified a muscle factor β-aminoisobutyric acid (BAIBA), which is produced by skeletal muscle during physical activity. BAIBA have been found to link with sedentary life style, abdominal obesity, and impairments in carbohydrate and lipid metabolism. A few studies have shown that BAIBA can protect from diet-induced obesity in animal models. It induces transition of white adipose tissue to a "beige" phenotype, which induces fatty acids oxidation and increases insulin sensitivity. While the exact mechanisms of BAIBA-induced metabolic effects are still not well understood, the aim of this study is want to study its relationship with muscle wasting and insulin resistance in a group of non-diabetic hemodialysis patients.

Read the detailed description

Study Design and Population

Patients and Methods

This study is an observational, cross-sectional and prospective cohort study. One hundred and fifty patients on non-diabetic hemodialysed patients will be included for the cross-sectional survey; Twenty healthy subjects will be elected as the controls. Prevalent adult HD patients with dialysis vintages over 3 months will be recruited. Patients are maintained on regular HD prescription, three times a week, for four-hour sessions. Subjects with significant comorbid conditions such as cancer, heart failure, or severe liver disease and chronic infection such diabetic foot will be excluded. This study is conducted according to the guidelines laid down in the Declaration of Helsinki, and all procedures were reviewed as well as approved by the Regional Hospital Ethics Committee. All subjects should give their written informed consent to participate in the study. Subjects' demographic and clinical characteristics, including age, gender, weight, height, body mass index (BMI), dialysis vintage, and Kt/V will be recorded, and comorbidities and current therapies will be collected.

Anthropometric and biochemical assessments

Systolic and diastolic blood pressures are taken with the subjects in the supine position. A measurement of height and weight was performed on all subjects. Waist circumference was measured at the midpoint between the lower border of the rib cage and the iliac bone. The concentration of plasma insulin was assayed by radioimmunoassay. Fasting plasma glucose was measured using the glucose oxidase method. HbA1c was measured by affinity chromatography. Total cholesterol, triglyceride, and HDL cholesterol levels were measured enzymatically using an autoanalyzer (Hitachi 747; Hitachi, Tokyo, Japan). Serum insulin concentrations are determined by IRMA. Adiponectin and leptin concentrations are measured using a commercially available ELISA kit.

Sample preparation

In each subject, the blood samples are drawn from the arteriovenous fistula in of each participant in the morning after fasting for at least 8 h and on the day of hemodialysis. The samples are properly processed, refrigerated at 2-8 C, and the plasma is separated immediately by centrifugation. Each serum sample is heat-inactivated by incubation at 65 C for 30 min. Fetal bovine serum (FBS; Gibco BRL, Grand Island, NY, USA), a negative control, is treated with activated charcoal (Sigma, St. Louis, MO, USA) overnight at 4 C and filtered to remove all small molecules and AhR agonists that might have been present. TCDD, a positive control for AhR agonists, was purchased from Sigma Co. Plasma BAIBA levels are assessed by a Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, as previously described (15). Cell-based AhR ligand activity (CALA) assay and ELISA assay will be performed (16)

HOMA-IR, HOMA-%B, HOMA-%S, and disposition index are calculated by the following formulae.

HOMA-IR1 = [fasting insulin (mU/l) × fasting glucose(mg/dl)× 0.0555]/22.5 HOMA-%B1 = [20 × fasting insulin (mU/l)]/[(fasting glucose(mg/dl) × 0.0555)-3.5] HOMA-%S1 = [1/ HOMA-IR1] × 100% Disposition index 1= (HOMA-%S1/100) × (HOMA-%B1/100)

Dual-Energy X-ray Absorptiometry (DEXA)

DEXA is a widely used reference method for body FFM and FM measurements.(10) DEXA was performed using a Lunar Prodigy (GE Medical Systems, Madison, WI). Whole-body scans were performed according to manufacturer's instructions, and body FM (FMDEXA), LTM (LTMDEXA) and bone mineral content were analyzed using the manufacturer's software. The DEXA method uses an X-ray tube with a filter to generate low-energy (40 kV) and high-energy (70 or 100 kV) photons. When photons at different energy levels pass through tissue, their absorptions can be expressed as a ratio of attenuation at lower or higher energy levels. DEXA estimate of FFM was calculated as a sum of LTMand bone mineral content estimates. All patients were examined by the same observer.

Bioelectric Impedance Spectroscopy

Whole-body bioelectric impedance spectroscopy (BIS) measurement using a body composition monitor (BCM: Fresenius Medical Care, Bad Homburg, Germany) was performed on each of the participants enrolled in the study by a specific member of the staff who had completed a training course in the BCM technique. The BCM measures the impedance spectroscopy at 50 different frequencies between 5 kHz and 1 MHz. Measurements were taken on the day before dialysis with the patient calm, supine, and relaxed in the dialysis bed for 10minutes. Four electrodes were placed on the patient's hand and foot on the side contra lateral to their arteriovenous fistula. Specific exclusion criteria were dictated by the device and included history of a pacemaker, defibrillator, metallic sutures, or stent implantation and amputation of a major limb. As a multifrequency bioimpedance device, BCM not only provides extracellular (ECWBCM), intracellular (ICWBCM), and total body water (TBWBCM) measurements but also estimates the body composition in terms of lean tissue mass (LTMBCM-mainly muscle), fat mass (FATBCM), adipose tissue mass (ATMBCM-mainly fat), and overhydration (OH) according to the body compositionmodel.(17) This device combined BIS with the BCM model described in Chamney et al,11 and it takes into account the dissimilar hydration of relevant tissues. Briefly, the device was modified to reflect the presence of excess fluid accumulated due to pathologic reasons, that is, patients with kidney failure. It has therefore set constants for each of the body composition compartment. This device has been shown to be as precise as the gold standardreference methods and has been validated against reference methods for volume status and body composition assessments in healthy and HD populations, with methods frequently used in the 4-compartment model. The percentage proportions of LTMBCM, FATBCM, andATMBCM were denoted accordingly as pLTMBCM, pFATBCM, and pATMBCM.

Muscle Strength

The muscle function will be assessed on the same day of the recruitment immediately before starting the HD session by handgrip strength measurement, using a handle dynamometer. The test is performed conducting three attempts with each hand, and the mean of the strongest hand is used to determine muscle strength

Keywords
Insulin resistance, Sarcopenia, β-aminoisobutyric acid
Medical subject headings
Sarcopenia, Insulin Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analysis of biomarkers of β-aminoisobutyric Acid( L-BAIBA) levels

    BAIBA can protect from diet-induced obesity in animal models. It induces transition of white adipose tissue to a "beige" phenotype, which induces fatty acids oxidation and increases insulin sensitivity.

    Measured: 1 years

Secondary outcomes (1)
  1. Presence of Sarcopenia

    To evaluate the association of sacropenia defined according to 1. Muscle Strength 2. Bioelectric Impedance Spectroscopy 3. Dual-Energy X-ray Absorptiometry (DEXA)

    Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2020
  2. Study start10 Mar 2020
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04309201
Sponsor's protocol ID
108084
Status last verified
Jan 2021
First submitted
12 Mar 2020
Last updated
1 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Insulin Resistance, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.

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 1 inclusion and 4 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 1 Feb 2021. 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 Taiwan. 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. 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?

Analysis of biomarkers of β-aminoisobutyric Acid( L-BAIBA) levels (time frame: 1 years). 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 1 Feb 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in