Could Single-anastomosis Gastric Bypass Be a Curative Treatment for Type II Diabetes?

Not Applicable

Suspended

• Conditions: Metabolic Surgery

• Registration Number: NCT03412253
• Lead Sponsor: Ain Shams University

Brief Summary

Single- Anastomosis gastric bypass (SAGB) is a potentially curative line of treatment for type II diabetes mellitus (T2DM) patients with BMI 25-30 kg/m2. Accordingly, SAGB could be integrated into T2DM treatment algorithm

Detailed Description

Background: T2DM has been considered as a chronic progressive incurable metabolic disease. Single-anastomosis gastric bypass (SAGB) was shown to be effective in obese patients in terms of weight reduction and T2DM remission, yet its effect on non-obese diabetics is not extensively studied. In this study, we tried to determine the anthropometric and glycemic outcomes of SAGB as a proposed line of treatment for type II diabetes mellitus (T2DM) patients with body mass index (BMI) 25-30 kg/m2.

Methods: From November 2013 to March 2016, a prospective study has been conducted at Ain-Shams University hospitals on 17 consecutive patients undergone SAGB. The demographic and anthropometric data of the patients, as well as their relevant laboratory results, were reported, other data including anti-diabetic medications, co-morbid metabolic diseases were also assessed. All patients were scheduled for laparoscopic SAGB and were advised to come in regular follow up at 1, 3, 6, 12 and 18 months postoperatively. T2DM Remission is considered if glycosylated hemoglobin (HbA1c) \<6.5 % and fasting plasma glucose (FPG) \< 126 mg/dl for at least 1 year without medication.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-11-01
• Primary Completion: 2016-03-31
• Status Verified: 2018-01
• Study First Submitted: 2018-01-13
• Study First Submitted QC: 2018-01-20
• Last Update Submitted: 2018-01-20
• Study First Posted: 2018-01-26
• Last Update Posted: 2018-01-26
• Study Completion: 2018-02-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

.Type II diabetic patients.

• Age: 20-60 years.
• either gender.

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Exclusion Criteria

• Previous bariatric surgery.
• Controlled T2DM.
• Duration of T2DM >10 years.
• Patients with endocrinal diseases,
• Pregnancy.
• Those unfit for general anesthesia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cure of type II DM.	1Year	T2DM Remission is considered if glycosylated hemoglobin (HbA1c) \<6.5 % and fasting plasma glucose (FPG) \< 126 mg/dl for at least 1 year without medication.