NCT03412253

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

Trial Health

20
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2018

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

January 13, 2018

Last Update Submit

January 20, 2018

Conditions

Metabolic Surgery

Keywords

metabolic surgery, BMI 25-30 kg/m2, SAGB, T2DM remission.

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Single-Anastomosis Gastric Bypass surgery (SAGB).PROCEDURE

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

Also known as: Mini-Gastric Bypass., One-Anastomosis Gastric Bypass.

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type II diabetic patients.
  • Age: 20-60 years.
  • either gender.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2018

First Posted

January 26, 2018

Study Start

November 1, 2013

Primary Completion

March 31, 2016

Study Completion

February 4, 2018

Last Updated

January 26, 2018

Record last verified: 2018-01