Surgical Intervention for the Treatment of Diabetes in Overweight Non-responders-1
- Conditions
- OverweightDiabetes Mellitus, Type 2
- Interventions
- Procedure: Sleeve Gastrectomy with Ileal TranspositionProcedure: Sleeve Gastrectomy with Transit BipartitionOther: Medical Treatment
- Registration Number
- NCT02610530
- Lead Sponsor
- Turkish Metabolic Surgery Foundation
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Surgery-A Sleeve Gastrectomy with Ileal Transposition Overweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2. who underwent sleeve gastrectomy with ileal transposition Surgery-B Sleeve Gastrectomy with Transit Bipartition Overweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2. who underwent sleeve gastrectomy with transit bipartition Non-Surgery Medical Treatment 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.
- Primary Outcome Measures
Name Time Method Reduction in glycated hemoglobin (HbA1c) 1 year Complete diabetic remission (HbA1c \< 6%) and partial diabetic remission (HbA1c= 6-6.5%) without medication.
- Secondary Outcome Measures
Name Time Method Hypertension Control 1 year Systolic blood pressure (BP) \<130 mm Hg and diastolic BP \<80 mm Hg, without medication.
Weight Control 1 year Amount of weight loss in kilograms.
Change in LDL (low-density lipoprotein) Cholesterol 1 year \<100 mg/dL, without medication.
Change in HDL (high-density lipoprotein) Cholesterol 1 year \>40 mg/dL, without medication.
Change in Triglycerides 1 year \<150 mg/dL, without medication.