UMIN-CTR Clinical Trial

Public title

Sarcopenia in hemodialysis patients and blood ghrelin and leptin concentration

Acronym

Sarcopenia in hemodialysis patients and blood ghrelin and leptin concentration

Scientific Title

Sarcopenia in hemodialysis patients and blood ghrelin and leptin concentration

Scientific Title:Acronym

Sarcopenia in hemodialysis patients and blood ghrelin and leptin concentration

Region

Japan

Condition

Chronic renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine whether blood ghrelin and leptin concentrations are involved in the development of sarcopenia in hemodialysis patients

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Difference in blood ghrelin and leptin levels between hemodialysis patients complicated with or without sarcopenia

Key secondary outcomes

Difference in dietary intake and appetite between hemodialysis patients complicated with or without sarcopenia

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

100

years-old

>

Gender

Male and Female

Key inclusion criteria

Hemodialysis patients in our hospital outpatient clinic

Key exclusion criteria

Patients complicated with serious diseases such as cancer, hematological disorders, and liver cirrhosis

Target sample size

20

Name of lead principal investigator

1st name	Michio
Middle name
Last name	Kuwahara

Organization

Saitama Tsukinomori Clinic

Division name

Nephrology

Zip code

339-0012

Address

366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan

TEL

048-792-1811

Email

kuwahara@k-naika-cl.jp

Name of contact person

1st name	Megumi
Middle name
Last name	Kobayashi

Organization

Saitama Tsukinomori Clinic

Division name

Nutrition

Zip code

339-0012

Address

366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan

TEL

048-792-1811

Homepage URL

Email

kobayashim@k-naika-cl.jp

Institute

Saitama Tsukinomori Clinic

Institute

Department

Personal name

Organization

Saitama Tsukinomori Clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

the ethics committee of Saitama Tsukinomori Clinic

Address

366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan

Tel

0487921811

Email

kuwahara@k-naika-cl.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

10

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

1. In 10 hemodialysis patients receiving cinacalcet, leptin was 0.67+0.09 (Log [leptin ng/mL]), active ghrelin was 1.22+0.13 (Log [active ghrelin fmol/mL]), and desacyl ghrelin was 2.15+0.18 (Log [desacyl ghrelin fmol/mL]).
2. In these patients, 8 weeks after changing from cinacalcet to evocalcet, leptin was 0.70+0.12 (Log [leptin ng/mL]) and active ghrelin was 1.37+0.11 (Log [active ghrelin fmol/mL]) , Desacyl ghrelin was 2.08+0.20 (Log [desacyl ghrelin fmol/mL]), and no significant change was observed.

Results date posted

2020

Year

10

Month

27

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2018

Year

10

Month

23

Day

Date of IRB

2018

Year

10

Month

23

Day

Anticipated trial start date

2018

Year

10

Month

24

Day

Last follow-up date

2020

Year

10

Month

01

Day

Date of closure to data entry

2020

Year

10

Month

01

Day

Date trial data considered complete

2020

Year

10

Month

01

Day

Date analysis concluded

2020

Year

10

Month

01

Day

Other related information

The main results of this study are as follows.
1. Blood levels of leptin, activated ghrelin and desacyl ghrelin were measured in 70 dialysis patients in a pilot study. Although these values had a non-normal distribution, we found that they can be regarded as a normal distribution by logarithmic transformation. Therefore, statistical processing was performed using the logarithmic conversion value.
2. In 10 hemodialysis patients receiving cinacalcet, leptin was 0.67+0.09 (Log [leptin ng/mL]), active ghrelin was 1.22+0.13 (Log [active ghrelin fmol/mL]), and desacyl ghrelin was 2.15+0.18 (Log [desacyl ghrelin fmol/mL]).
3. In these patients, 8 weeks after changing from cinacalcet to evocalcet, leptin was 0.70+0.12 (Log [leptin ng/mL]) and active ghrelin was 1.37+0.11 (Log [active ghrelin fmol/mL]) , Desacyl ghrelin was 2.08+0.20 (Log [desacyl ghrelin fmol/mL]), and no significant change was observed.
Our hypothesis was that "after changing from cinacalcet to evocalcet, leptin decreases and active ghrelin increases," but the results did not match the hypothesis. Therefore, we conclude that further research is difficult.

Registered date

2018

Year

10

Month

24

Day

Last modified on

2020

Year

10

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039470