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Completed

NCT Number: NCT01559779

Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function

The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric procedure that changes the gastrointestinal anatomy and has been demonstrated to cause remission of type 2 diabetes shortly after the operation, before any significant weight loss. The altered transit of nutrient through the gastrointestinal tract after the operation is thought to play a key role in this remission and studies have shown significant changes in the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1). However it is unknown whether the secretory function of the pancreatic islets as well as the stimulatory effect of the incretin hormones is changes postoperatively.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dpt. of Endocrinology (215) at Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Normal glucose tolerance
  • Age > 18 years
  • BMI > 40 or > 35 if combined with hypertension or obstructive sleep apnoea
  • Caucasian
  • Normal hemoglobinaemia
  • Signed informed consent

Exclusion criteria

  • Major psychiatric disorder
  • Alcohol or drug abuse
  • Major hearth or pulmonary disease
  • Previous major abdominal disease (e.g. peritonitis, large hernia)
  • Pregnancy/lactation
  • Treatment with GLP-1 analogs

Treatment and study plan

Primary outcomes

  1. Change in beta cell function

    Time frame: Before and 1 week and 3 months after surgery

    Change in first and second phase insulin response, disposition index, and acute insulin secretion in response to a non-glucose stimulus

  2. Insulinotropic effect of incretin hormones

    Time frame: Before and 1 week and 3 months after surgery

    Change in first and second phase insulin response during GLP-1 and GIP infusion compared to saline

Secondary outcomes

  1. Change in alpha cell function

    Time frame: Before and 1 week and 3 months after surgery

    Change in glucagon secretion in response to glucose and non-glucose stimuli

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

The Effect of Gastric Bypass Surgery on the Beta- and Alpha Cells Secretory Function and the Insulinotropic Effect of the Incretin Hormones

Acronym: AB-CD-10

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 21, 2012
Registry last updated
Jun 10, 2014

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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