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Comparison Between Patients With or Without Diabetes Recovery After Bariatric Surgery

U

University of Campinas, Brazil

Status

Completed

Conditions

Diabetes
Bariatric Surgery
Obesity

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT00834938
LIMED0005

Details and patient eligibility

About

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.

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

24 participants in 2 patient groups

1
Description:
Patients with DM2 undergoing RYGB with remission of DM2
Treatment:
Other: No intervention
2
Description:
Patients with DM2 undergoing RYGB without remission of DM2
Treatment:
Other: No intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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