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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
History of Changes

November 24, 2011
November 29, 2011
May 2007
October 2011   (final data collection date for primary outcome measure)
Diabetes resolution at 12 months after surgery [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01481675 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Diabetes Resolution and Hormone Changes After BPDLL and LSG
Resolution of Diabetes and Hormonal Changes Following Biliopancreatic Diversion Long Limbs and Laparoscopic Sleeve Gastrectomy. A Comparative Prospective Study.

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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
Diabetes Mellitus
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01481675
BPDLSG002, BPDLL vs LSG
No
Theodore K. Alexandrides, University of Patras
University of Patras
Not Provided
Principal Investigator: Theodore Alexandrides, Professor University of Patras
Study Director: Fotis Kalfarentzos, Professor University of Patras
University of Patras
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP