New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I

Obesity Clinical Trial

Official title:

New Frontiers on Bariatric Surgical Procedures. Classical Bypass for Type 2 Diabetic Patients With BMI Between 30 and 34.9 kg/m2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566189
• Other study ID #: LIMED0004
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 30, 2007
• Last updated: March 7, 2013
• Start date: August 2007
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.

This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.

Description:

Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases; most of the remainder achieve better glycemic control, even if they regain weight. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.

Actually, many clinical researchers worldwide would consider a lower limit BMI of 30kg/m2, i.e., any grade of obesity.

This study is proposed to describe the effects of Roux-en-Y gastric bypass (Fobi-Capella technique, adapted to create a larger gastric pouch, about 80ml)in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Obesity grade I (BMI 30-34,9)

• Weight variance less than 5% in the last 3 months.

• Previous diagnosis of diabetes type 2.

• Insulin requirement, alone or along with oral agents

• Capacity to understand the procedures of the study.

• To agree voluntarily to participate of the study, signing an informed consent.

Exclusion Criteria:

• Positive Anti-GAD antibodies

• Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL.

• History of hepatic disease like cirrhosis or chronic active hepatitis.

• Kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men).

• Hepatic dysfunction: aspartate aminotransferase or alanine aminotransferase 3x above upper normal limit.

• Recent history of neoplasia (< 5 years).

• Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Obesity

Intervention

Procedure:
• Roux-en-Y Bypass Gastroplasty
Under open laparotomy, a stomach section separates a 80-ml proximal gastric pouch. A jejunum section below Treitz's Angle creates an excluded gastrobiliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the continuity between the gastric pouch and the jejunum and a silastic ring reduces the pouch outlet.The anastomosis of the excluded limb is done 100cm below the silastic ring.

Locations

Country	Name	City	State
Brazil	LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)	Campinas	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Ethicon Endo-Surgery

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Geloneze B, Tambascia MA, Pareja JC, Repetto EM, Magna LA. The insulin tolerance test in morbidly obese patients undergoing bariatric surgery. Obes Res. 2001 Dec;9(12):763-9. — View Citation

Geloneze B, Tambascia MA, Pilla VF, Geloneze SR, Repetto EM, Pareja JC. Ghrelin: a gut-brain hormone: effect of gastric bypass surgery. Obes Surg. 2003 Feb;13(1):17-22. — View Citation

Pories WJ, MacDonald KG Jr, Flickinger EG, Dohm GL, Sinha MK, Barakat HA, May HJ, Khazanie P, Swanson MS, Morgan E, et al. Is type II diabetes mellitus (NIDDM) a surgical disease? Ann Surg. 1992 Jun;215(6):633-42; discussion 643. — View Citation

Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. — View Citation

Pories WJ. Diabetes: the evolution of a new paradigm. Ann Surg. 2004 Jan;239(1):12-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement or reversal of type 2 diabetes mellitus		7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year.	No
Secondary	Changes in body weight and fat distribution after intervention		1 month, 2 months, 3 months, 6 months and 1 year	No
Secondary	Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test		6 months and 1 year	No
Secondary	Improvement of insulin sensitivity as measured by insulin tolerance test		1 month, 3 months, 6 months and 1 year	No
Secondary	Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines		one month, 2 months, 3 months, 6 months and 1 year	No
Secondary	Regression of carotid intima-media thickness		1 month, 3 months, 6 months and 1 year	No
Secondary	Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography		1 year and 2 years	No
Secondary	Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography		1 year and 2 years	No
Secondary	Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection		6 months, 1 year and 2 years	No