Surgical Intervention for the Treatment of Diabetes in Overweight Non-responders-1

Study Overview
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Brief Summary
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The SIT-DOWN study is a single centered retrospective study in which a total of 90 (ninety) participants who are overweight (BMI: 25-29.9 kg/m2) and have type 2 diabetes mellitus (T2DM) will be evaluated for the efficacy of surgical intervention in comparison with medical treatment. Primary endpoint of the study will be the change in glycemic regulation by the end of 12 months.

Detailed Description
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Use of bariatric/metabolic surgery has conventionally been reserved for those whose body-mass index (BMI) is 35 kg/m2 or greater. Trials in these morbidly obese patients confirmed the benefits in terms of weight loss and provide evidence that surgery can result in remission of diabetes, and as a result lead to improvement in cardiovascular risk factors. Within the light of these data, there appear to be a shift towards lower BMI, with many advocating it as a reasonable option for diabetics with a lower BMI (<30) who have failed other attempts of medical treatment. But this approach is limited because of lack of data on the effects of surgical outcomes in this group of patients which is the main rationale for this retrospective study.

Official Title
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Efficacy of Surgical Intervention for the Treatment of Diabetes Mellitus Type 2 in Overweight Non-responders in Comparison With Conventional Nonsurgical Medical Treatment

Conditions
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Overweight, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Procedure: Sleeve Gastrectomy with Ileal Transposition
* Procedure: Sleeve Gastrectomy with Transit Bipartition
* Other: Medical Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight, type 2 diabetic: Type 2 diabetes diagnosis longer than 3 years; BMI= 25-29.9 kg/m2 Participants with baseline HbA1c ≥ % 7.5, not achieved HbA1c < % 7.3 at 3 months on therapy Absence of co-morbidities (neuropathy, retinopathy, cardiovascular disease, stroke events or lower extremity amputation). Exclusion Criteria: Liver cirrhosis, severe renal failure, collagen diseases, severe endocrinopathies, blindness. Heart failure, acute myocardial infarction, stroke or transient ischemic attack, unstable angina pectoris. History of malignancy or malignant neoplasm in place, severe inflammatory complications, neurological or cardiovascular in act. Pregnancy Any conditions that at the discretion of the head of the study can represent risk to the participant or could affect the protocol results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Surgery<br>Overweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2 who have been on medical treatment for glycemic control. | Other: Medical Treatment<br>* Conventional Non-Surgical Treatment for Glycemic Control group consisted of patients who did not undergo any kind of surgery, and are on medical treatment for type 2 diabetes.<br>* Other names: Oral antidiabetics and / or insulin;|
| Surgery-A<br>Overweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2. who underwent sleeve gastrectomy with ileal transposition | Procedure: Sleeve Gastrectomy with Ileal Transposition<br>* Type 2 diabetic patients who underwent ileal transposition surgery within the last 2 years.<br>|
| Surgery-B<br>Overweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2. who underwent sleeve gastrectomy with transit bipartition | Procedure: Sleeve Gastrectomy with Transit Bipartition<br>* Type 2 diabetic patients who underwent transit bipartition surgery within the last 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in glycated hemoglobin (HbA1c) | Complete diabetic remission (HbA1c < 6%) and partial diabetic remission (HbA1c= 6-6.5%) without medication. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension Control | Systolic blood pressure (BP) <130 mm Hg and diastolic BP <80 mm Hg, without medication. | 1 year | 
| Change in LDL (low-density lipoprotein) Cholesterol | <100 mg/dL, without medication. | 1 year | 
| Change in HDL (high-density lipoprotein) Cholesterol | >40 mg/dL, without medication. | 1 year | 
| Change in Triglycerides | <150 mg/dL, without medication. | 1 year | 
| Weight Control | Amount of weight loss in kilograms. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, metabolic surgery, medical treatment