A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus (Advanced medical care A)

Not Applicable

Recruiting

• Conditions: Morbid obese patients with diabetes mellitus

• Registration Number: JPRN-UMIN000030837
• Lead Sponsor: Tohoku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-01
• Last Update Posted: 17 October 2023
• Study Completion: 2024-02-01

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

1, Patiens mental disorders are clearly involved in morbid obesity Background 2, Secondary obesity associated with endocrine disorders 3, Patients determined not to be expected the effect of weight loss surgery 4, Patients with severe renal dysfunction 5, Patients with severe liver failure 6, Pregnant women or women who may possibly be pregnant 7, Patients determined to be inappropriate as a test subject by investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate safety Confirm postoperative complications within 30 post operative days To evaluate efficacy HbA1c at 12months after surgery

Secondary Outcome Measures

Name	Time	Method
To evaluate safety 1, Confirm the presence or absence of malnutrition after the operation at 12months after surgery To evaluate efficacy 1, Effect on weight loss 2, Confirm medication status of diabetes drugs at 12months after surgery