Efficacy of Surgical Intervention for the Treatment of Diabetes Mellitus Type 2 in Overweight Non-responders in Comparison With Conventional Nonsurgical Medical Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 主要终点
- Reduction in glycated hemoglobin (HbA1c)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Reduction in glycated hemoglobin (HbA1c)
时间窗: 1 year
Complete diabetic remission (HbA1c \< 6%) and partial diabetic remission (HbA1c= 6-6.5%) without medication.
次要结局
- Hypertension Control(1 year)
- Weight Control(1 year)
- Change in LDL (low-density lipoprotein) Cholesterol(1 year)
- Change in HDL (high-density lipoprotein) Cholesterol(1 year)
- Change in Triglycerides(1 year)