NCT00834938

Brief Summary

Bariatric surgery can lead to improvement or even resolution of type 2 diabetes in about 80% of patients submitted to Roux-en-Y gastric bypass (RYGP). Otherwise, many patients experienced no resolution of their diabetes despite massive surgical-induced weight loss. There appears to be a variable response to surgery depending on surgical and patient factors. To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed to make a description of effects of surgical procedures on incretin, insulin production and sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

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

July 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 11, 2011

Status Verified

August 1, 2011

Enrollment Period

1 year

First QC Date

February 2, 2009

Last Update Submit

August 9, 2011

Conditions

DiabetesBariatric SurgeryObesity

Keywords

diabetes mellitus, type 2Insulin resistancebariatric surgeryGlucagon-Like Peptide 1Gastric Inhibitory PolypeptideinsulinglucagonghrelinadiponectinCytokinesgastric bypassObesity

Outcome Measures

Primary Outcomes (1)

  • Describe the endogenous response of incretins, orexins and anorexins to a mixed meal test in obese patients with DM2, in patients with DM2 undergoing RYGB with remission of DM2 and in patients without remission.

    2 years after RYGB

Study Arms (2)

1

Patients with DM2 undergoing RYGB with remission of DM2

Other: No intervention

2

Patients with DM2 undergoing RYGB without remission of DM2

Other: No intervention

Interventions

No interventionOTHER

No intervention

12

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with DM2 and obesity undergoing RYGB with remission of DM2 and without remission.

You may qualify if:

  • Capacity to understand the procedures of the study.
  • To agree voluntarily to participate of the study, signing an informed consent.
  • Weight variance less than 5% in the last 3 months.
  • Operative group with at least 2 year follow-up.

You may not qualify if:

  • 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: ALT and/or AST 3x above upper normal limit).
  • Recent history of neoplasia (\< 5 years).
  • Use of oral or injectable 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 (4)

  • 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

  • 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

  • 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

MeSH Terms

Conditions

Diabetes MellitusObesityDiabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinism

Study Officials

  • José Carlos Pareja, MD, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

  • Bruno Geloneze, MD, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

July 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2010

Last Updated

August 11, 2011

Record last verified: 2011-08

Locations

BR(1)