Could Single-anastomosis Gastric Bypass Be a Curative Tre... | NCT03412253

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

NCT03412253

Sponsor

Ain Shams University

Status

Suspended

Last Update Posted

Jan 26, 2018Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Metabolic Surgery

Interventions

Single-Anastomosis Gastric Bypass surgery (SAGB).

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

financial causes, and the study will be continued within days.

Expanded Access Info

Start Date

Nov 1, 2013Actual

Primary Completion Date

Mar 31, 2016Actual

Completion Date

Feb 4, 2018Estimated

First Submitted Date

Jan 13, 2018

First Submission Date that Met QC Criteria

Jan 20, 2018

First Posted Date

Jan 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2018

Last Update Posted Date

Jan 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tarek Abouzeid Osman Abouzeid, Principal Investigator, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single-Anastomosis Gastric Bypass surgery (SAGB).	Procedure	We checked the effect of SAGB on patients suffered from T2DM with BMI 25-30		Mini-Gastric Bypass. One-Anastomosis Gastric Bypass.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cure of type II DM.	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.	1Year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided