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

NCT02610530 | Unknown

• 1 other identifier: 2015/S01
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight; Diabetes Mellitus, Type 2

Keywords

type 2 diabetes; metabolic surgery; medical treatment

Outcome Measures

Primary Outcomes (1)

• Reduction in glycated hemoglobin (HbA1c)

  Complete diabetic remission (HbA1c \< 6%) and partial diabetic remission (HbA1c= 6-6.5%) without medication.

  1 year

Secondary Outcomes (5)

• Hypertension Control

  1 year

• Change in LDL (low-density lipoprotein) Cholesterol

  1 year

• Change in HDL (high-density lipoprotein) Cholesterol

  1 year

• Change in Triglycerides

  1 year

• Weight Control

  1 year

Study Arms (3)

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.

Other: Medical Treatment

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

Procedure: 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

Procedure: Sleeve Gastrectomy with Transit Bipartition

Interventions

Sleeve Gastrectomy with Ileal Transposition PROCEDURE

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

Surgery-A

Sleeve Gastrectomy with Transit Bipartition PROCEDURE

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

Surgery-B

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.

Also known as: Oral antidiabetics and / or insulin

Non-Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turkish Metabolic Surgery Foundation: lead

Related Publications (9)

• 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.

  PMID: 18830747 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.

  PMID: 20029383 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.

  PMID: 25469034 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.

  PMID: 23439632 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.

  PMID: 24646534 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.

  PMID: 25027983 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.

  PMID: 22609843 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.

  PMID: 21557013 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.

  PMID: 20096647 BACKGROUND

MeSH Terms

Conditions

Overweight; Diabetes Mellitus, Type 2

Interventions

Hypoglycemic Agents; Insulin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Alper Celik, MD

  Turkish Metabolic Surgery Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 1, 2016

Record last verified: 2016-07