Diabetes Resolution and Hormone Changes After BPDLL and LSG

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theodore K. Alexandrides, University of Patras
ClinicalTrials.gov Identifier:
NCT01481675
First received: November 24, 2011
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2.


Condition
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Resolution of Diabetes and Hormonal Changes Following Biliopancreatic Diversion Long Limbs and Laparoscopic Sleeve Gastrectomy. A Comparative Prospective Study.

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Diabetes resolution at 12 months after surgery [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight loss at 12 months after surgery [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
  • Changes of GLP-1 response to glucose [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
  • Changes in ghrelin levels [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
  • Changes in PYY response to glucose [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
BPDLL group
Patients subjected to the Biliopancreatic Diversion Long Limbs surgical operation will undergo an oral glucose tolerance preoperatively and 12 months after the operation
LSG group
Patients subjected to laparoscopic sleeve gastrectomy will undergo an oral glucose tolerance test preoperatively and 12 months postoperatively

Detailed Description:

Twelve patients with diabetes mellitus type 2 (DM 2) and body mass index (BMI)> 50kg/m2) will undergo BPDLL and 12 twelve patients with DM 2 and BMI 40-50 kg/m2 will undergo LSG. The patients will be evaluated before and 1, 3 and 12 months after surgery with an oral glucose tolerance test. The investigators aim to investigate the effects of surgery on diabetes resolution, hypertension, dyslipidemia, and also on fasting, and glucose-stimulated insulin, glucagon, ghrelin, peptide-YY and glucagon-like peptide-1 (GLP-1) responses during during an oral glucose tolerance test (OGTT). Resolution of diabetes mellitus will be evaluated according to the criteria of American Diabetes Association with an OGTT. The effects on appetite and satiety will be also evaluated with the use of visual analog scores.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Twelve patients with diabetes mellitus type 2 and BMI> 50kg/m2 will undergo BPDLL and 12 patients with diabetes mellitus type 2 and BMI 40-50kg/m2 will undergo LSG

Criteria

Inclusion Criteria:

  • BMI>50kg/m2 to undergo BPDLL
  • BMI 40-50kg/m2 to undergo LSG
  • Diabetes mellitus type 2

Exclusion Criteria:

  • Chronic medical illness
  • Psychiatric illness
  • Substance abuse
  • Previous gastrointestinal surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481675

Locations
Greece
University Hospital of Patras
Rion, Achaia, Greece, 26504
University Hospital of Patras
Rion, Achaia, Greece, 26500
Sponsors and Collaborators
University of Patras
Investigators
Principal Investigator: Theodore Alexandrides, Professor University of Patras
Study Director: Fotis Kalfarentzos, Professor University of Patras
  More Information

No publications provided

Responsible Party: Theodore K. Alexandrides, Professor of Medicine, Head of Endocrine Division, University of Patras
ClinicalTrials.gov Identifier: NCT01481675     History of Changes
Other Study ID Numbers: BPDLSG002, BPDLL vs LSG
Study First Received: November 24, 2011
Last Updated: November 29, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by University of Patras:
biliopancreatic diversion
sleeve gastrectomy
diabetes mellitus
weight loss
ghrelin
PYY
GLP-1

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014