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Early Sleeve Gastrectomy In New Onset Diabetic Obese Patients

NCT02488733 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-26

No results posted yet for this study

Summary

Bariatric surgery is efficient in both inducing adequate weight loss and the control of glycemia in obese patients affected by Type 2 Diabetes Mellitus (T2DM).

Despite growing evidence suggesting that early performance of bariatric surgery on obese patients with T2DM offers the best opportunity to reach and maintain a remission of diabetes, no randomized clinical trials (RCT) have evaluated its efficiency in patients with new T2DM diagnosis.

The aim of this RCT is to compare bariatric surgery, and in particular Laparoscopic Sleeve Gastrectomy (LSG), with conventional medical therapy (CMT) in patients with new T2DM diagnosis that are obese (Body Mass Index, BMI of between 30 and 42 Kg/m2), to be recruited at two Italian diabetology centres (Terni and Rome).

The main objective of the present RCT is to investigate the efficacy of LSG as compared with CMT in inducing and maintaining both a resolution of T2DM (defined as HbA1c levels ≤6.0%, without active pharmacologic therapy or ongoing procedures) and the remission of T2DM through the evaluation of the criteria provided by the American Diabetes Association (ADA) at maximum follow-up of 6 years. The effects of the two treatments in terms of weight loss and the quality of life of the patient will also be taken into consideration.

Any positive results of this study will include preventing microvascular and macrovascular complications connected with diabetes, without the necessity to take medication, and at the same time the loss of excess body weight and improved quality of life (QOL).

Conditions

Interventions

PROCEDURE

LSG

In addition to all previously described aspects of conventional medical therapy, patients assigned to surgical treatment will undergo LSG, to be performed in accordance with current international guidelines

DRUG

CMT

CMT consists in the use of the best treatment strategies, involving pharmacological and dietary therapies, lifestyle and physical activity, with the aim of both glycemic control and weight loss, administered on the basis of the current guidelines of the American Diabetes Association (ADA)\[50\] and determined on an individual basis \[52\].The administration of such pharmacological and non-pharmacological therapies will be adjusted in accordance with the algorithms of the ADA .

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    collaborator INDUSTRY

  • Azienda Ospedaliera Santa Maria, Terni, Italy

    lead OTHER

Principal Investigators

  • Stefano Trastulli, MD · Azienda Ospedaliera Santa Maria di Terni

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02488733 on ClinicalTrials.gov