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Completed

NCT Number: NCT00834938

Comparison Between Patients With or Without Diabetes Recovery After Bariatric Surgery

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Campinas, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

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.

    Time frame: 2 years after RYGB

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Long Term Effects of Bariatric Surgery on Diabetes: Comparison Between Patients With or Without Diabetes Recovery.

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Feb 3, 2009
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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