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

NCT ID: NCT02610530

Last Updated: 2016-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-10-31

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.

Conditions

Overweight; Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Medical Treatment

Intervention Type: 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.

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

Sleeve Gastrectomy with Ileal Transposition

Intervention Type: PROCEDURE

Type 2 diabetic patients who underwent ileal transposition surgery within the last 2 years.

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

Sleeve Gastrectomy with Transit Bipartition

Intervention Type: PROCEDURE

Type 2 diabetic patients who underwent transit bipartition surgery within the last 2 years.

Interventions

Sleeve Gastrectomy with Ileal Transposition

Type 2 diabetic patients who underwent ileal transposition surgery within the last 2 years.

Intervention Type: PROCEDURE

Sleeve Gastrectomy with Transit Bipartition

Type 2 diabetic patients who underwent transit bipartition surgery within the last 2 years.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Other Intervention Names

Oral antidiabetics and / or insulin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turkish Metabolic Surgery Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alper Celik, MD

Role: PRINCIPAL_INVESTIGATOR

Turkish Metabolic Surgery Foundation

References

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.

Reference Type: BACKGROUND

PMID: 18830747 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20029383 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25469034 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23439632 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24646534 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25027983 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22609843 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21557013 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20096647 (View on PubMed)

Other Identifiers

2015/S01

Identifier Type: -

Identifier Source: org_study_id