NCT00566189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

4 years

First QC Date

November 30, 2007

Last Update Submit

March 7, 2013

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceObesity

Keywords

diabetes mellitus, type 2Insulin resistanceIntra-Abdominal FatOmentumduodenal exclusionbariatric surgeryGlucagon-Like Peptide 1Gastric Inhibitory PolypeptideinsulinglucagonghrelinadiponectinCytokines

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (8)

  • Changes in body weight and fat distribution after intervention

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

  • 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

  • Improvement of insulin sensitivity as measured by insulin tolerance test

    1 month, 3 months, 6 months and 1 year

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

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

  • Regression of carotid intima-media thickness

    1 month, 3 months, 6 months and 1 year

  • +3 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Roux-en-Y bypass gastroplasty

Procedure: Roux-en-Y Bypass Gastroplasty

Interventions

Roux-en-Y Bypass GastroplastyPROCEDURE

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.

Also known as: Roux-en-Y Gastric Bypass
1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Campinas, São Paulo, Brazil

Location

Related Publications (6)

  • 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.

    PMID: 14685094BACKGROUND

  • 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.

    PMID: 7677463BACKGROUND

  • 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.

    PMID: 1632685BACKGROUND

  • 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.

    PMID: 12630608BACKGROUND

  • 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.

    PMID: 11743060BACKGROUND

  • 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.

    PMID: 25098565DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceObesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • José Carlos Pareja, MD, PhD

    University of Campinas (UNICAMP)

    PRINCIPAL INVESTIGATOR

  • Bruno Geloneze, MD, PhD

    University of Campinas (UNICAMP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr Bruno Geloneze, MD, PhD

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 3, 2007

Study Start

August 1, 2007

Primary Completion

August 1, 2011

Study Completion

December 1, 2012

Last Updated

March 8, 2013

Record last verified: 2013-03

Locations

BR(1)