UMIN-CTR Clinical Trial

Public title

Docosahexaenoic acid supplementation as an add-on therapy to eicosapentaenoic acid changes the estimated glomerular filtration rate decline into positive slope in type 2 diabetes patients.

Acronym

Docosahexaenoic acid supplementation as an add-on therapy to eicosapentaenoic acid changes the estimated glomerular filtration rate decline into positive slope in type 2 diabetes patients.

Scientific Title

Docosahexaenoic acid supplementation as an add-on therapy to eicosapentaenoic acid changes the estimated glomerular filtration rate decline into positive slope in type 2 diabetes patients.

Scientific Title:Acronym

Docosahexaenoic acid supplementation as an add-on therapy to eicosapentaenoic acid changes the estimated glomerular filtration rate decline into positive slope in type 2 diabetes patients.

Region

Japan

Condition

type 2 diabetes, diabetic kidney disease

Classification by specialty

Endocrinology and Metabolism

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to investigate the effect of Long-chain omega-3 polyunsaturated fatty acids (LCO3FAs) supplementation, including eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA), on diabetic kidney disease (DKD).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

The change of eGFR, which was calculated by subtracting eGFR at the initiation of EPA administration (baseline) from eGFR after 12 months.

Key secondary outcomes

The secondary outcomes were the changes in of BMI, BP, UACR, E-A ratio, HbA1c, UA, TG, TC, LDL-C, HDL-C, L-H ratio and non-HDL-C

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

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

The subject were type 2 diabetic outpatients who were newly prescribed EPA (ethyl icosapentate: 1800mg/day) for managing hypertriglyceridemia or due to the diagnosis of having cardiovascular disease (CVD) risk.

Key exclusion criteria

We excluded patients who have any one of the following criteria: [1] receiving hemodialysis; [2] being suspected of having kidney disease other than DKD; [3] being suspected of having muscle atrophy because of gait disturbance; [4] being treated with SGLT2i and GLP-1RAs; [5] received additional prescription of new class of glucose-lowering drugs, or new agents which can influence eGFR, within one year from the initiation of EPA administration; [6] new onset of systemic disease; [7] whose eGFR was measured less than six times during the follow-up period.

Target sample size

100

Name of lead principal investigator

1st name	Kazuaki
Middle name
Last name	Nakai

Organization

Ehime Rousai Hospital

Division name

Department of Internal Medicine

Zip code

792-0863

Address

13-27 Minamikomatubaracho, Niihama, Ehime 792-0863, Japan

TEL

0897-33-6191

Email

knakai@ehimeh.johas.go.jp

Name of contact person

1st name	Kazuaki
Middle name
Last name	Nakai

Organization

Ehime Rousai Hospital

Division name

Department of Internal Medicine

Zip code

792-0863

Address

13-27 Minamikomatubaracho, Niihama, Ehime 792-0863, Japan

TEL

0897-33-6191

Homepage URL

Email

knakai@ehimeh.johas.go.jp

Institute

Department of Internal Medicine,Ehime Rousai Hospital, Niihama, Japan

Institute

Department

Personal name

Organization

none in particular

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ehime Rousai Hospital Clinical Trial Ethics Review Committee

Address

13-27 Minamikomatubaracho, Niihama, Ehime 792-0863, Japan

Tel

0897-33-6191

Email

soumuka@ehimeh.johas.go.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

2020

Year

10

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

128

Results

We collected 128 patients. Of the 128 patients, 28 patients'prescriptions were switched to the combination of EPA and DHA after the initiation of EPA (E/D group). The remaining 100 patients continued taking EPA (E group).12 months after, the average of the change of eGFR showed significantly increase in the E/D group and values greatly differed between the two groups. A significant difference was still observed between the two groups after adjusting for the difference in the baseline covariates.

Results date posted

2020

Year

09

Month

30

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

Completed

Date of protocol fixation

2020

Year

06

Month

01

Day

Date of IRB

2020

Year

09

Month

14

Day

Anticipated trial start date

2020

Year

06

Month

02

Day

Last follow-up date

2020

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

retrospective study

Registered date

2020

Year

09

Month

23

Day

Last modified on

2020

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047775