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Diabetes Resolution and Hormone Changes After BPDLL and LSG

U

University of Patras

Status

Completed

Conditions

Diabetes Mellitus

Study type

Observational

Funder types

Other

Identifiers

NCT01481675
BPDLL vs LSG (Other Identifier)
BPDLSG002

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No 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

Trial design

24 participants in 2 patient groups

BPDLL group
Description:
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
Description:
Patients subjected to laparoscopic sleeve gastrectomy will undergo an oral glucose tolerance test preoperatively and 12 months postoperatively

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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