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

From Diabetes Care to Diabetes Cure; Could Single-anastomosis Gastric Bypass Be a Safe Bridge to Reach This Target in Non-Obese Patients?

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03412253
Enrollment
17
Registered
2018-01-26
Start date
2013-11-01
Completion date
2018-02-04
Last updated
2018-01-26

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

Conditions

Metabolic Surgery

Keywords

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

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.

Interventions

PROCEDURESingle-Anastomosis Gastric Bypass surgery (SAGB).

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cure of type II DM.1YearT2DM Remission is considered if glycosylated hemoglobin (HbA1c) \<6.5 % and fasting plasma glucose (FPG) \< 126 mg/dl for at least 1 year without medication.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026