UMIN-CTR Clinical Trial

Public title

Prevalence of gastroesophageal reflux evaluated by upper gastrointestinal tract examination in ataff health check, and its associations with metabolic syndrome.

Acronym

GERD and metabolic syndrome

Scientific Title

Prevalence of gastroesophageal reflux evaluated by upper gastrointestinal tract examination in ataff health check, and its associations with metabolic syndrome.

Scientific Title:Acronym

GERD and metabolic syndrome

Region

Japan

Condition

Gastroesophageal reflux disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We investigate the association of the gastroesphageal reflux severity in upper gastrointestinal tract examination with metabolic syndrome.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

(1) Prevalence of gastroesophageal reflux disease in stuff members undergoing upper gastro intestinal X-ray examination in health check.
(2) Relationship between severity of gastroesophageal reflux and metabolic marker.

Key secondary outcomes

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

40

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

Indivisuals who agree to participation of this study.

Key exclusion criteria

Indivisuals who have any disease such as aliment disease or medical treatment were excluded.

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Hidekazu Suzuki

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology, Department of Internal Medicine

Zip code

Address

35 Shinanomachi, Shinjuku-ku

TEL

03-3353-1211

Email

Name of contact person

1st name
Middle name
Last name	Eisuke Iwasaki

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology, Department of Internal Medicine

Zip code

Address

TEL

Homepage URL

Email

e-iwa@sc.itc.keio.ac.jp

Institute

Division of Gastroenterology, Department of Internal Medicine, Keio University School of Medicine

Institute

Department

Personal name

Organization

Donation

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2007

Year

09

Month

01

Day

URL releasing protocol

http://www.ncbi.nlm.nih.gov/pubmed/20482701

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/20482701

Number of participants that the trial has enrolled

Results

Two hundred and eighty-three subjects (243 men and 40 women; mean age 49.8 +/- 6.9 years) with no radiographic evidence of erosive esophagitis were enrolled. The severity of GER was worse among men than among women, whereas the severity of reflux symptoms was worse among women. The severity of GER was associated with age and serum triglyceride levels in men, and with the serum low-density lipoprotein cholesterol levels in women. The severity of reflux symptoms, however, was not associated with metabolic parameters. There were more women than men with reflux symptoms but without GER ('presumed' functional heartburn group), compared with subjects with neither GER nor reflux symptoms. In men, the presence of both reflux symptoms and GER ('presumed' NERD group) was associated with the serum triglyceride levels.
CONCLUSIONS & INFERENCES: While NERD is associated with serum lipid levels, functional heartburn is not. The prevalence of GER was greater among men; conversely, the prevalence of functional heartburn was greater among women.

Results date posted

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

2006

Year

08

Month

31

Day

Date of IRB

Anticipated trial start date

2006

Year

09

Month

01

Day

Last follow-up date

2007

Year

08

Month

01

Day

Date of closure to data entry

2007

Year

08

Month

01

Day

Date trial data considered complete

2007

Year

08

Month

01

Day

Date analysis concluded

2007

Year

12

Month

01

Day

Other related information

The relationship between metabolic syndrome and gastroesophageal reflux disease remains unclarified. At their visit, all individuals complete the Carlsson-Dent Self-Administered Questionnaire (Scand. J. Gastroenterol. 33: 1023, 1998). The findings of upper gastrointestinal tract X-ray examination were evaluated by the Keio video X-ray reflux scores (Am. J. Gastroenterol. 101:S56, 2006), which have been defined for the diagnosis of functional gastro-esophageal reflux.
The X-ray scores were assessed in relation to the body mass index, blood pressure, waist circumference, serum levels of adiponectin and triglyceride, blood glucose, plasma ghrelin and the homeostasis model assessment of insulin resistance (HOMA-IR).

Registered date

2007

Year

02

Month

20

Day

Last modified on

2010

Year

08

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000744