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

Metabolic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03412253
• Other study ID #: A1349
• Status: Suspended
• Phase: N/A
• First received: January 13, 2018
• Last updated: January 20, 2018
• Start date: November 1, 2013
• Est. completion date: February 4, 2018

Study information

• Verified date: January 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 17
• Est. completion date: February 4, 2018
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Surgery

Intervention

Procedure:
• Single-Anastomosis Gastric Bypass surgery (SAGB).
We checked the effect of SAGB on patients suffered from T2DM with BMI 25-30

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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