Comparison Between Patients With or Without Diabetes Recovery After Bariatric Surgery

NCT ID: NCT00834938

Last Updated: 2011-08-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Diabetes reversion is observed after bariatric surgeries even before significant weight loss could explain it, mainly in predominantly malabsorptive procedures (98,9% for biliopancreatic diversion or duodenal switch), followed by those combining malabsorption and gastric restriction (83,7% for Roux-en-Y gastric bypass). Changes in the hormonal communication between the digestive system and the pancreas would explain the antidiabetogenic role of the surgery, so this effect could be obtained in nonobese, diabetic individuals.

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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Diabetes Bariatric Surgery Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Patients with DM2 undergoing RYGB with remission of DM2

No intervention

Intervention Type OTHER

No intervention

2

Patients with DM2 undergoing RYGB without remission of DM2

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Campinas, Brazil

OTHER

Sponsor Role lead

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

Site Status

Countries

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Brazil

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.

Reference Type BACKGROUND
PMID: 12630608 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11743060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1632685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14685094 (View on PubMed)

Other Identifiers

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LIMED0005

Identifier Type: -

Identifier Source: org_study_id

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