Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Surgery | 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. |
| |
| Surgery-A | 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 | Overweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2. who underwent sleeve gastrectomy with transit bipartition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeve Gastrectomy with Ileal Transposition | Procedure | Type 2 diabetic patients who underwent ileal transposition surgery within the last 2 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in glycated hemoglobin (HbA1c) | Complete diabetic remission (HbA1c < 6%) and partial diabetic remission (HbA1c= 6-6.5%) without medication. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension Control | Systolic blood pressure (BP) <130 mm Hg and diastolic BP <80 mm Hg, without medication. | 1 year |
| Change in LDL (low-density lipoprotein) Cholesterol | <100 mg/dL, without medication. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Overweight, type 2 diabetic: Type 2 diabetes diagnosis longer than 3 years; BMI= 25-29.9 kg/m2
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alper Celik, MD | Turkish Metabolic Surgery Foundation | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18830747 | Background | DePaula AL, Macedo AL, Schraibman V, Mota BR, Vencio S. Hormonal evaluation following laparoscopic treatment of type 2 diabetes mellitus patients with BMI 20-34. Surg Endosc. 2009 Aug;23(8):1724-32. doi: 10.1007/s00464-008-0168-6. Epub 2008 Oct 2. | |
| 20029383 | Background | Kashyap SR, Daud S, Kelly KR, Gastaldelli A, Win H, Brethauer S, Kirwan JP, Schauer PR. Acute effects of gastric bypass versus gastric restrictive surgery on beta-cell function and insulinotropic hormones in severely obese patients with type 2 diabetes. Int J Obes (Lond). 2010 Mar;34(3):462-71. doi: 10.1038/ijo.2009.254. Epub 2009 Dec 22. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
| ID | Term |
|---|---|
| D007004 | Hypoglycemic Agents |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011384 | Proinsulin |
Not provided
Not provided
Not provided
Not provided
Not provided
| Sleeve Gastrectomy with Transit Bipartition | Procedure | Type 2 diabetic patients who underwent transit bipartition surgery within the last 2 years. |
|
| Medical Treatment | Other | 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. |
|
|
| 1 year |
| Change in HDL (high-density lipoprotein) Cholesterol | >40 mg/dL, without medication. | 1 year |
| Change in Triglycerides | <150 mg/dL, without medication. | 1 year |
| Weight Control | Amount of weight loss in kilograms. | 1 year |
| 25469034 | Background | Finelli C, Padula MC, Martelli G, Tarantino G. Could the improvement of obesity-related co-morbidities depend on modified gut hormones secretion? World J Gastroenterol. 2014 Nov 28;20(44):16649-64. doi: 10.3748/wjg.v20.i44.16649. |
| 23439632 | Background | Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, Abdul-Ghani M, Abood B, Pothier CE, Brethauer S, Nissen S, Gupta M, Kirwan JP, Schauer PR. Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: analysis of a randomized control trial comparing surgery with intensive medical treatment. Diabetes Care. 2013 Aug;36(8):2175-82. doi: 10.2337/dc12-1596. Epub 2013 Feb 25. |
| 24646534 | Background | Santoro S. From Bariatric to Pure Metabolic Surgery: New Concepts on the Rise. Ann Surg. 2015 Aug;262(2):e79-80. doi: 10.1097/SLA.0000000000000590. No abstract available. |
| 25027983 | Background | Celik A, Ugale S. Functional restriction and a new balance between proximal and distal gut: the tools of the real metabolic surgery. Obes Surg. 2014 Oct;24(10):1742-3. doi: 10.1007/s11695-014-1368-x. No abstract available. |
| 22609843 | Background | Santoro S, Castro LC, Velhote MC, Malzoni CE, Klajner S, Castro LP, Lacombe A, Santo MA. Sleeve gastrectomy with transit bipartition: a potent intervention for metabolic syndrome and obesity. Ann Surg. 2012 Jul;256(1):104-10. doi: 10.1097/SLA.0b013e31825370c0. |
| 21557013 | Background | De Paula AL, Stival AR, Halpern A, DePaula CC, Mari A, Muscelli E, Vencio S, Ferrannini E. Improvement in insulin sensitivity and beta-cell function following ileal interposition with sleeve gastrectomy in type 2 diabetic patients: potential mechanisms. J Gastrointest Surg. 2011 Aug;15(8):1344-53. doi: 10.1007/s11605-011-1550-6. Epub 2011 May 10. |
| 20096647 | Background | De Paula AL, Stival AR, Macedo A, Ribamar J, Mancini M, Halpern A, Vencio S. Prospective randomized controlled trial comparing 2 versions of laparoscopic ileal interposition associated with sleeve gastrectomy for patients with type 2 diabetes with BMI 21-34 kg/m(2). Surg Obes Relat Dis. 2010 May-Jun;6(3):296-304. doi: 10.1016/j.soard.2009.10.005. Epub 2009 Nov 10. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |