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

Primary Purpose

Diabetes Mellitus, Type 2, Insulin Resistance, Obesity

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Roux-en-Y Bypass Gastroplasty

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes mellitus, type 2, Insulin resistance, Intra-Abdominal Fat, Omentum, duodenal exclusion, bariatric surgery, Glucagon-Like Peptide 1, Gastric Inhibitory Polypeptide, insulin, glucagon, ghrelin, adiponectin, Cytokines

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Roux-en-Y bypass gastroplasty

Outcomes

Primary Outcome Measures

Improvement or reversal of type 2 diabetes mellitus

Secondary Outcome Measures

Changes in body weight and fat distribution after intervention

Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test

Improvement of insulin sensitivity as measured by insulin tolerance test

Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines

Regression of carotid intima-media thickness

Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography

Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography

Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection

Full Information

NCT ID

NCT00566189

First Posted

November 30, 2007

Last Updated

March 7, 2013

Sponsor

University of Campinas, Brazil

Collaborators

Ethicon Endo-Surgery

1. Study Identification

Unique Protocol Identification Number

NCT00566189

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Campinas, Brazil

Collaborators

Ethicon Endo-Surgery

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Insulin Resistance, Obesity

Keywords

diabetes mellitus, type 2, Insulin resistance, Intra-Abdominal Fat, Omentum, duodenal exclusion, bariatric surgery, Glucagon-Like Peptide 1, Gastric Inhibitory Polypeptide, insulin, glucagon, ghrelin, adiponectin, Cytokines

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Roux-en-Y bypass gastroplasty

Intervention Type

Procedure

Intervention Name(s)

Roux-en-Y Bypass Gastroplasty

Other Intervention Name(s)

Roux-en-Y Gastric Bypass

Intervention Description

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.

Primary Outcome Measure Information:

Title

Improvement or reversal of type 2 diabetes mellitus

Time Frame

7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year.

Secondary Outcome Measure Information:

Title

Changes in body weight and fat distribution after intervention

Time Frame

1 month, 2 months, 3 months, 6 months and 1 year

Title

Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test

Time Frame

6 months and 1 year

Title

Improvement of insulin sensitivity as measured by insulin tolerance test

Time Frame

1 month, 3 months, 6 months and 1 year

Title

Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines

Time Frame

one month, 2 months, 3 months, 6 months and 1 year

Title

Regression of carotid intima-media thickness

Time Frame

1 month, 3 months, 6 months and 1 year

Title

Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography

Time Frame

1 year and 2 years

Title

Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography

Time Frame

1 year and 2 years

Title

Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection

Time Frame

6 months, 1 year and 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José Carlos Pareja, MD, PhD

Organizational Affiliation

University of Campinas (UNICAMP)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bruno Geloneze, MD, PhD

Organizational Affiliation

University of Campinas (UNICAMP)

Official's Role

Principal Investigator

Facility Information:

Facility Name

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)

City

Campinas

State/Province

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

14685094

Citation

Pories WJ. Diabetes: the evolution of a new paradigm. Ann Surg. 2004 Jan;239(1):12-3. doi: 10.1097/01.sla.0000102990.47956.98.

Results Reference

background

PubMed Identifier

7677463

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. doi: 10.1097/00000658-199509000-00011.

Results Reference

background

PubMed Identifier

1632685

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. doi: 10.1097/00000658-199206000-00010.

Results Reference

background

PubMed Identifier

12630608

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. doi: 10.1381/096089203321136539.

Results Reference

background

PubMed Identifier

11743060

Citation

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. doi: 10.1038/oby.2001.105.

Results Reference

background

PubMed Identifier

25098565

Citation

Fellici AC, Lambert G, Lima MM, Pareja JC, Rodovalho S, Chaim EA, Geloneze B. Surgical treatment of type 2 diabetes in subjects with mild obesity: mechanisms underlying metabolic improvements. Obes Surg. 2015 Jan;25(1):36-44. doi: 10.1007/s11695-014-1377-9.

Results Reference

derived

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

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