Surgical Intervention for the Treatment of Diabetes in Overweight Non-responders-1 (SIT-DOWN-1)

Turkish Metabolic Surgery Foundation

Status

Unknown

Conditions

Overweight

Diabetes Mellitus, Type 2

Treatments

Procedure: Sleeve Gastrectomy with Transit Bipartition

Procedure: Sleeve Gastrectomy with Ileal Transposition

Other: Medical Treatment

Study type

Observational

Funder types

Other

Identifiers

NCT02610530

2015/S01

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.