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OpenTrials
Completed

NCT Number: NCT02360878

The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones

We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose metabolism as well as gut and pancreatic hormone secretion.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Hellerup, 2900, Denmark

About this study

Duodenal-jejunal bypass sleeve (DJBS) is being developed for the treatment of obesity, and initial clinical outcomes suggest that this minimally invasive endoscopic technique potentially has beneficial effects on type 2 diabetes also. However, the mechanisms behind the antidiabetic effects of the procedure remain unknown. We want to elucidate how the DJBS might change postprandial secretion of gut and pancreatic hormones.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

(obese subjects with type 2 diabetes):

  • treatment with DJBS
  • written informed consent
  • antidiabetic monotherapy/or diet
  • > 18 years old
  • not anemic

Exclusion criteria

(obese subjects with type 2 diabetes):

  • antidiabetic treatment with insulin, GLP-1-agonists, DPP4-inhibitors or more than one orally administered antidiabetic drug.
  • anemia

Inclusion criteria

(obese subjects without type 2 diabetes):

  • Treatment with DJBS
  • written informed consent
  • not anemic
  • HbA1c < 6,0% or HbA1c < 6,5% and normal glucose tolerance test and normal fasting plasma glucose (< 6,0 mM)

Exclusion criteria

(obese subjects without type 2 diabetes):

  • HbA1c > 6,5 % and/or a non-normal glucose tolerance test and/or fasting plasma glucose > 6,0 mM

Treatment and study plan

EndoBarrier Gastrointestinal Liner

Device

Implantation with the EndoBarrier

Other names: DJBS

Primary outcomes

  1. Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  2. Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 26 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  3. Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 52 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  4. Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 3 weeks after explantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

Secondary outcomes

  1. Change in basal metabolic rate from baseline 1 week after implantation

    Time frame: 0, 50, 210 minutes

  2. Change in basal metabolic rate from baseline 26 weeks after implantation

    Time frame: 0, 50, 210 minutes

  3. Change in basal metabolic rate from baseline 52 weeks after implantation

    Time frame: 0, 50, 210 minutes

  4. Change in basal metabolic rate from baseline 3 weeks after explantation

    Time frame: 0, 50, 210 minutes

  5. Change in gastric emptying from baseline 1 week after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  6. Change in gastric emptying from baseline 26 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  7. Change in gastric emptying from baseline 52 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  8. Change in gastric emptying from baseline 3 weeks after explantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  9. Change in gallbladder emptying from baseline 1 week after implantation

    Time frame: 0, 20, 40, 60, 90, 120, 150, 180

  10. Change in gallbladder emptying from baseline 26 weeks after implantation

    Time frame: 0, 20, 40, 60, 90, 120, 150, 180

  11. Change in gallbladder emptying from baseline 52 weeks after implantation

    Time frame: 0, 20, 40, 60, 90, 120, 150, 180

  12. Change in gallbladder emptying from baseline 3 weeks after explantation

    Time frame: 0, 20, 40, 60, 90, 120, 150, 180

  13. Change in satiety scores as measured by Visual Analogue Scales 1 week after implantation

    Time frame: 0, 30, 60, 90, 120, 180, 240

  14. Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation

    Time frame: 0, 30, 60, 90, 120, 180, 240

  15. Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation

    Time frame: 0, 30, 60, 90, 120, 180, 240

  16. Change in satiety scores as measured by Visual Analogue Scales 3 weeks after explantation

    Time frame: 0, 30, 60, 90, 120, 180, 240

  17. Change in postprandial insulin secretion from baseline 1 week after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  18. Change in postprandial insulin secretion from baseline 26 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  19. Change in postprandial insulin secretion from baseline 52 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  20. Change in postprandial insulin secretion from baseline 3 weeks after explantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  21. Change in postprandial glucagon secretion 1 week after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  22. Change in postprandial glucagon secretion 26 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  23. Change in postprandial glucagon secretion 52 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  24. Change in postprandial glucagon secretion 3 weeks after explantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  25. Change in postprandial glucose from baseline 1 week after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  26. Change in postprandial glucose from baseline 26 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  27. Change in postprandial glucose from baseline 52 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  28. Change in postprandial glucose form baseline 3 weeks after explantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  29. Change in postprandial PYY from baseline 1 week after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  30. Change in postprandial PYY from baseline 26 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  31. Change in postprandial PYY from baseline 52 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  32. Change in postprandial PYY from baseline 3 weeks after explantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  33. Change in postprandial ghrelin from baseline 1 week after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  34. Change in postprandial ghrelin from baseline 26 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  35. Change in postprandial ghrelin from baseline 52 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  36. Change in postprandial ghrelin from baseline 3 weeks after explantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  37. Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 1 week after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  38. Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 26 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  39. Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 52 weeks after implantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  40. Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 3 weeks after explantation

    Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

Other outcomes

  1. Change in gut microbiota as measured by DNA sequencing from baseline

    Time frame: 52 weeks

  2. Change in body composition from baseline 26 weeks after implantation

    Time frame: 1

  3. Change in body composition from baseline 52 weeks after implantation

    Time frame: 1

  4. Change in caloric intake as measured by ad libitum meal test 1 week after implantation

    Time frame: 30 minutes

  5. Change in caloric intake as measured by ad libitum meal test 26 weeks after implantation

    Time frame: 30 minutes

  6. Change in caloric intake as measured by ad libitum meal test 52 weeks after implantation

    Time frame: 30 minutes

  7. Change in caloric intake as measured by ad libitum meal test 3 weeks after explantation

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Filip Krag Knop

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2015
Registry last updated
Aug 10, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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