Diabetes Resolution and Hormone Changes After BPDLL and LSG

Sponsor

University of Patras (Other)

Overall Status

Completed

CT.gov ID

NCT01481675

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus

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.

Study Design

Study Type:

Observational

Actual Enrollment :

24 participants

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.

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Diabetes resolution at 12 months after surgery [12 months after surgery]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Patras	Rion	Achaia	Greece	26500
2	University Hospital of Patras	Rion	Achaia	Greece	26504

Sponsors and Collaborators

University of Patras

Investigators

Principal Investigator: Theodore Alexandrides, Professor, University of Patras
Study Director: Fotis Kalfarentzos, Professor, University of Patras

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Theodore K. Alexandrides, Professor of Medicine, Head of Endocrine Division, University of Patras

ClinicalTrials.gov Identifier:

NCT01481675

Other Study ID Numbers:

BPDLSG002
BPDLL vs LSG

First Posted:

Nov 29, 2011

Last Update Posted:

Nov 30, 2011

Last Verified:

Nov 1, 2011

Keywords provided by Theodore K. Alexandrides, Professor of Medicine, Head of Endocrine Division, University of Patras

biliopancreatic diversion

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

No Results Posted as of Nov 30, 2011