Comparison Between Patients With or Without Diabetes Recovery After Bariatric Surgery
NCT ID: NCT00834938
Last Updated: 2011-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2007-07-31
2010-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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1
Patients with DM2 undergoing RYGB with remission of DM2
No intervention
No intervention
2
Patients with DM2 undergoing RYGB without remission of DM2
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Campinas, Brazil
OTHER
Responsible Party
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UNICAMP
Principal Investigators
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José Carlos Pareja, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Campinas, Brazil
Bruno Geloneze, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Campinas, Brazil
Locations
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LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
Campinas, São Paulo, Brazil
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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LIMED0005
Identifier Type: -
Identifier Source: org_study_id
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