Diabetes Resolution and Hormone Changes After BPDLL and LSG

Diabetes Mellitus Clinical Trial

Official title:

Resolution of Diabetes and Hormonal Changes Following Biliopancreatic Diversion Long Limbs and Laparoscopic Sleeve Gastrectomy. A Comparative Prospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481675
• Other study ID #: BPDLSG002
• Secondary ID: BPDLL vs LSG
• Status: Completed
• Phase: N/A
• First received: November 24, 2011
• Last updated: November 29, 2011
• Start date: May 2007
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
Greece	University Hospital of Patras	Rion	Achaia
Greece	University Hospital of Patras	Rion	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes resolution at 12 months after surgery		12 months after surgery	No
Secondary	Weight loss at 12 months after surgery		12 months after surgery	No
Secondary	Changes of GLP-1 response to glucose		12 months after surgery	No
Secondary	Changes in ghrelin levels		12 months after surgery	No
Secondary	Changes in PYY response to glucose		12 months after surgery	No