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

Diabetes Mellitus, Type 2 Clinical Trial

— SIT-DOWN-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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02610530
• Other study ID #: 2015/S01
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 17, 2015
• Last updated: July 29, 2016
• Start date: December 2015
• Est. completion date: October 2016

Study information

• Verified date: July 2016
• Source: Turkish Metabolic Surgery Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Overweight

Intervention

Procedure:
• Sleeve Gastrectomy with Ileal Transposition
Type 2 diabetic patients who underwent ileal transposition surgery within the last 2 years.
• Sleeve Gastrectomy with Transit Bipartition
Type 2 diabetic patients who underwent transit bipartition surgery within the last 2 years.

Other:
• Medical 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turkish Metabolic Surgery Foundation

References & Publications (9)

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. — View Citation

De Paula AL, Stival AR, Halpern A, DePaula CC, Mari A, Muscelli E, Vencio S, Ferrannini E. Improvement in insulin sensitivity and ß-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. — View 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. — View Citation

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. — View Citation

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in glycated hemoglobin (HbA1c)	Complete diabetic remission (HbA1c < 6%) and partial diabetic remission (HbA1c= 6-6.5%) without medication.	1 year	No
Secondary	Hypertension Control	Systolic blood pressure (BP) <130 mm Hg and diastolic BP <80 mm Hg, without medication.	1 year	No
Secondary	Change in LDL (low-density lipoprotein) Cholesterol	<100 mg/dL, without medication.	1 year	No
Secondary	Change in HDL (high-density lipoprotein) Cholesterol	>40 mg/dL, without medication.	1 year	No
Secondary	Change in Triglycerides	<150 mg/dL, without medication.	1 year	No
Secondary	Weight Control	Amount of weight loss in kilograms.	1 year	No