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

A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus - A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016208

Enrollment

Registered

2015-02-01

Start date

2015-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid obese patients with diabetes mellitus

Interventions

Opetarion Laparoscopic sleeve gastrectomy/duodenojejunal bypass

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1, Age: 18-65 years of age 2, Gender: unquestioned 3, BMI: 32Kg/m2 or more 4, Less than 5 points in the m-ABCD score 5, including patients whose effects after laparoscopic sleeve-gastrectomy are not sufficient, satisfying above criteria 1-4

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To evaluate safety Confirm postoperative complications within 30 post operative days To evaluate efficacy HbA1c at 12months after surgery	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactNaoki Tanaka

Tohoku University Hospital Department of surgery

n-tanaka@surg1.med.tohoku.ac.jp022-717-7205

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026