Early Sleeve Gastrectomy In New Onset Diabetic Obese Patients

NCT02488733 | Active Not Recruiting DMC

• 1 other identifier: ESINODOP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus; obesity; laparoscopic sleeve gastrectomy; bariatric surgery; metabolic surgery

Outcome Measures

Primary Outcomes (1)

• Rate of patients achieving diabetes resolution

  HbA1c levels ≤6.0%, without active pharmacologic therapy or ongoing procedures

  Assessed up to 1 year after randomization

Secondary Outcomes (18)

• Rate of patients achieving diabetes resolution

  assessed at 2, 3, 4, 5 and 6 years after randomization

• Rate of patients achieving diabetes complete remission (American Diabetes Association criteria)

  assessed at 2, 3, 4, 5, and 6 years after randomization

• Rate of patients achieving HbA1c levels ≤6.5%,

  assessed at 1, 2, 3, 4, 5,and 6 years after randomization

• Rate of patients achieving HbA1c levels ≤6.5%,

  assessed up at 1, 2, 3, 4, 5,and 6 years after randomization

• Rate of patients achieving prolonged remission (American Diabetes Association criteria)

  Assessed up at 6 years after randomization

Study Arms (2)

Laparoscopic Sleeve Gastrectomy (LSG)

EXPERIMENTAL

In addition to conventional medical therapy, patients assigned to surgical treatment will undergo LSG, to be performed in accordance with current international guidelines.

Procedure: LSG; Drug: CMT

Conventional medical therapy (CMT)

OTHER

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.

Drug: CMT

Interventions

LSG PROCEDURE

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

Laparoscopic Sleeve Gastrectomy (LSG)

CMT DRUG

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 .

Conventional medical therapy (CMT); Laparoscopic Sleeve Gastrectomy (LSG)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No contraindication for laparoscopic surgery or general anaesthesia.
• Age ≥20 and ≤65 years.
• BMI of between 30 and 42 kg/m2.
• Documented new diagnosis of Type 2 Diabetes Mellitus obtained according to the following American Diabetes Association parameters: fasting blood glucose ≥ 126 mg/dl (7.0 mmol/l) and/or HbA1c ≥ 6.5% and no more than 8 months from enrollment in the study.

You may not qualify if:

• Previous bariatric surgery or major abdominal surgery.
• Patients with T2DM diagnosis treated with insulin.
• Evidence of complications connected to diabetes at any stage (diabetic retinopathy, diabetic nephropathy/microalbuminuria, cardiovascular disease or neuropathy).
• Cardiovascular diseases such as ischemia / coronary artery disease, arrhythmia, peripheral vascular diseases, congestive heart failure, history of heart attacks.
• Kidney diseases including nephro-vascular hypertension, stenosis of the renal artery or chronic renal insufficiency.
• Pregnancy
• Diagnosis of psychiatric illness (including dementia, severe depression, history of suicide attempts) or abuse of alcohol or drugs in the previous 5 years.

Sponsors & Collaborators

• Azienda Ospedaliera Santa Maria, Terni, Italy: lead
• Ethicon Endo-Surgery: collaborator

Study Sites (2)

Ospedale Sandro Pertini

Rome, Italy

Location

Azienda Ospedaliera Santa Maria

Terni, 05100, Italy

Location

Related Links

• Official study website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Trastulli, MD

  Azienda Ospedaliera Santa Maria di Terni

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Azienda Ospedaliera Santa Maria, Terni, Italy

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 2, 2015
• Study Start: December 1, 2015
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

IT (2)