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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01481675

Enrollment

Registered

2011-11-29

Start date

2007-05-31

Completion date

2011-10-31

Last updated

2011-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

biliopancreatic diversion, sleeve gastrectomy, diabetes mellitus, weight loss, ghrelin, PYY, GLP-1

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Diabetes resolution at 12 months after surgery	12 months after surgery

Secondary

Measure	Time frame
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

Countries

Greece

Outcome results