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

Turkish Metabolic Surgery Foundation90 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Overweight Diabetes Mellitus, Type 2

Interventions

Sleeve Gastrectomy with Ileal TranspositionPROCEDURE

Type 2 diabetic patients who underwent ileal transposition surgery within the last 2 years.

Sleeve Gastrectomy with Transit BipartitionPROCEDURE

Type 2 diabetic patients who underwent transit bipartition surgery within the last 2 years.

Medical TreatmentOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Reduction in glycated hemoglobin (HbA1c)

Complete diabetic remission (HbA1c \< 6%) and partial diabetic remission (HbA1c= 6-6.5%) without medication.

Time frame: 1 year

Secondary Outcomes

Hypertension Control

Systolic blood pressure (BP) \<130 mm Hg and diastolic BP \<80 mm Hg, without medication.

Time frame: 1 year

Change in LDL (low-density lipoprotein) Cholesterol

\<100 mg/dL, without medication.

Time frame: 1 year

Change in HDL (high-density lipoprotein) Cholesterol

\>40 mg/dL, without medication.

Time frame: 1 year

Change in Triglycerides

\<150 mg/dL, without medication.

Time frame: 1 year

Weight Control

Amount of weight loss in kilograms.

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.