Clinical trial NCT02610530: Surgical Intervention for the Treatment of Diabetes in Overweight Non-responders-1
Official title: Efficacy of Surgical Intervention for the Treatment of Diabetes Mellitus Type 2 in Overweight Non-responders in Comparison With Conventional Nonsurgical Medical Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overweight
Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
metabolic surgery
medical treatment
Lead sponsor: Turkish Metabolic Surgery Foundation
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight, type 2 diabetic: Type 2 diabetes diagnosis longer than 3 years; BMI= 25-29.9 kg/m2

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in glycated hemoglobin (HbA1c)
timeFrame: 1 year
Secondary outcomes:
measure: Hypertension Control
timeFrame: 1 year
measure: Change in LDL (low-density lipoprotein) Cholesterol
timeFrame: 1 year
measure: Change in HDL (high-density lipoprotein) Cholesterol
timeFrame: 1 year
measure: Change in Triglycerides
timeFrame: 1 year
measure: Weight Control
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Turkish Metabolic Surgery Foundation
name: Alper Celik, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.