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NCT Number: NCT01481675

Diabetes Resolution and Hormone Changes After BPDLL and LSG

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.

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Key information

Conditions

Diabetes Mellitus Body Weight Body Weight Changes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Patras, Rio, Achaia, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diabetes resolution at 12 months after surgery

    Time frame: 12 months after surgery

Secondary outcomes

  1. Weight loss at 12 months after surgery

    Time frame: 12 months after surgery

  2. Changes of GLP-1 response to glucose

    Time frame: 12 months after surgery

  3. Changes in ghrelin levels

    Time frame: 12 months after surgery

  4. Changes in PYY response to glucose

    Time frame: 12 months after surgery

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Nov 29, 2011
Registry last updated
Nov 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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