Clinical trial

Early Sleeve Gastrectomy In New Onset Diabetic Obese Patients

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT02488733

Active, not recruitingNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes Mellitus

Full registry criteria

Inclusion Criteria: 1. No contraindication for laparoscopic surgery or general anaesthesia. 2. Age ≥20 and ≤65 years. 3. BMI of between 30 and 42 kg/m2. 4. 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. Exclusion Criteria: 1. Previous bariatric surgery or major abdominal surgery. 2. Patients with T2DM diagnosis treated with insulin. 3. Evidence of complications connected to diabetes at any stage (diabetic retinopathy, diabetic nephropathy/microalbuminuria, cardiovascular disease or neuropathy). 4. Cardiovascular diseases such as ischemia / coronary artery disease, arrhythmia, peripheral vascular diseases, congestive heart failure, history of heart attacks. 5. Kidney diseases including nephro-vascular hypertension, stenosis of the renal artery or chronic renal insufficiency. 6. Pregnancy 7. Diagnosis of psychiatric illness (including dementia, severe depression, history of suicide attempts) or abuse of alcohol or drugs in the previous 5 years.

Treatments and study arms

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

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 .

Primary outcomes

Rate of patients achieving diabetes resolutionAssessed up to 1 year after randomization

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

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Ospedale Sandro Pertini🇮🇹 Rome, Italy

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Azienda Ospedaliera Santa Maria🇮🇹 Terni, Italy

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