Safety of endoscopic intragastric balloo

Phase 1

Recruiting

• Conditions: Obesity with metabolic disease; Obesity, Metabolic disease; D009765

• Registration Number: JPRN-jRCTs042190108
• Lead Sponsor: Yamashita Taro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) BMI 27.5 kg / m2 or more
2) Metabolic disorders (Diabetes, hypertension, dyslipidemia, obesity according to the diagnostic criteria of the Japan Diabetes Society, The Japanese Society of Internal Medicine, Japan Arteriosclerosis Disease Prevention Guidelines)
3) Insufficient weight control in medical treatment including diet for more than 6 months
4) Age 20 to 80
5) Performance status (PS) is 0 or 1 by ECOG criteria
6) The latest inspection value within 7 days before registration (may be the same day one week before registration date) satisfies all the following.
1 white blood cell count less than 10,000 / mm3
2 number of neutrophils more than 1,500 / mm3
3 Hemoglobin more than 9.0 g / dL (no blood transfusion within 7 days prior to blood collection for the test used for registration)
4 platelet count more than 10 x 10 4 / mm 3
5 Total bilirubin less than 1.5 mg / dL
6 creatinine less than 2 mg / d

Exclusion Criteria

1) History of surgery on the stomach
2) Infections that require systemic treatment (except for viral hepatitis)
3) Women who are pregnant or have pregnancy possibility
4) Difficult to participate because it has a mental disease or symptoms that interfere with daily life.
5) Serious complications (heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction etc.)
6) In addition, research principal investigator or the research division physician judged inappropriate
7)Participants who have been given sufficient explanations, and with sufficient understanding and consent from the patients themselves for their participation in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of endoscopic intragastric balloon

Secondary Outcome Measures

Name	Time	Method
1. Changes in body composition (fat circumference, fat mass, lean mass, bone mass measured by impedance method or DXA method)<br>2. Transition of metabolic disease related markers<br>3. Changes in stool bacteria and virus flora