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.
2 other identifiers
observational
24
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2007
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 24, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedNovember 30, 2011
November 1, 2011
4.4 years
November 24, 2011
November 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diabetes resolution at 12 months after surgery
12 months after surgery
Secondary Outcomes (4)
Weight loss at 12 months after surgery
12 months after surgery
Changes of GLP-1 response to glucose
12 months after surgery
Changes in ghrelin levels
12 months after surgery
Changes in PYY response to glucose
12 months after surgery
Study Arms (2)
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
Eligibility Criteria
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
You may qualify if:
- BMI\>50kg/m2 to undergo BPDLL
- BMI 40-50kg/m2 to undergo LSG
- Diabetes mellitus type 2
You may not qualify if:
- Chronic medical illness
- Psychiatric illness
- Substance abuse
- Previous gastrointestinal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital of Patras
Rio, Achaia, 26500, Greece
University Hospital of Patras
Rio, Achaia, 26504, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Theodore Alexandrides, Professor
University of Patras
- STUDY DIRECTOR
Fotis Kalfarentzos, Professor
University of Patras
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Head of Endocrine Division
Study Record Dates
First Submitted
November 24, 2011
First Posted
November 29, 2011
Study Start
May 1, 2007
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
November 30, 2011
Record last verified: 2011-11