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Comparison Between Patients With or Without Diabetes Recovery After Bariatric Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00834938
Enrollment
24
Registered
2009-02-03
Start date
2007-07-31
Completion date
2010-07-31
Last updated
2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Diabetes, Obesity

Keywords

diabetes mellitus, type 2, Insulin resistance, bariatric surgery, Glucagon-Like Peptide 1, Gastric Inhibitory Polypeptide, insulin, glucagon, ghrelin, adiponectin, Cytokines, gastric bypass, Obesity

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.

Detailed 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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Campinas, Brazil
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026