Comparison Between Patients With or Without Diabetes Recovery After Bariatric Surgery

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT00834938
First received: February 2, 2009
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Diabetes
Bariatric Surgery
Obesity
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Long Term Effects of Bariatric Surgery on Diabetes: Comparison Between Patients With or Without Diabetes Recovery.

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2007
Study Completion Date: July 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with DM2 undergoing RYGB with remission of DM2
Other: No intervention
No intervention
Other Name: No intervention
2
Patients with DM2 undergoing RYGB without remission of DM2
Other: No intervention
No intervention
Other Name: No intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with DM2 and obesity undergoing RYGB with remission of DM2 and without remission.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00834938

Locations
Brazil
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
Campinas, São Paulo, Brazil
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: José Carlos Pareja, MD, PhD University of Campinas, Brazil
Principal Investigator: Bruno Geloneze, MD, PhD University of Campinas, Brazil
  More Information

Publications:
Responsible Party: Fernanda Maria Possidonio Filgueira Hirsch, UNICAMP
ClinicalTrials.gov Identifier: NCT00834938     History of Changes
Other Study ID Numbers: LIMED0005
Study First Received: February 2, 2009
Last Updated: August 9, 2011
Health Authority: Brazil: National Health Surveillance Agency
Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
diabetes mellitus, type 2
Insulin resistance
bariatric surgery
Glucagon-Like Peptide 1
Gastric Inhibitory Polypeptide
insulin
glucagon
ghrelin
adiponectin
Cytokines
gastric bypass
Obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Gastric Inhibitory Polypeptide
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014