Diabetes Mellitus, Type 2, Overweight
Conditions
Keywords
type 2 diabetes, metabolic surgery, medical treatment
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.
Interventions
PROCEDURESleeve Gastrectomy with Ileal Transposition
Type 2 diabetic patients who underwent ileal transposition surgery within the last 2 years.
Type 2 diabetic patients who underwent transit bipartition surgery within the last 2 years.
OTHERMedical Treatment
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.
Sponsors
Turkish Metabolic Surgery Foundation
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in glycated hemoglobin (HbA1c) | 1 year | Complete diabetic remission (HbA1c \< 6%) and partial diabetic remission (HbA1c= 6-6.5%) without medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypertension Control | 1 year | Systolic blood pressure (BP) \<130 mm Hg and diastolic BP \<80 mm Hg, without medication. |
| 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. |
| Weight Control | 1 year | Amount of weight loss in kilograms. |
Outcome results
None listed