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

NCT ID: NCT03412253

Last Updated: 2018-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-01

Study Completion Date

2018-02-04

Brief Summary

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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

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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.

Conditions

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Metabolic Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Single-Anastomosis Gastric Bypass surgery (SAGB).

We checked the effect of SAGB on patients suffered from T2DM with BMI 25-30

Intervention Type PROCEDURE

Other Intervention Names

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Mini-Gastric Bypass. One-Anastomosis Gastric Bypass.

Eligibility Criteria

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Inclusion Criteria

.Type II diabetic patients.

* Age: 20-60 years.
* either gender.

Exclusion Criteria

* Previous bariatric surgery.
* Controlled T2DM.
* Duration of T2DM \>10 years.
* Patients with endocrinal diseases,
* Pregnancy.
* Those unfit for general anesthesia.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Tarek Abouzeid Osman Abouzeid

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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A1349

Identifier Type: -

Identifier Source: org_study_id

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