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OpenTrials
Completed

NCT Number: NCT03046186

Physiological Effects of Gastric Sleeve Operation

After gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however to which extent is not fully established and furthermore, the mechanisms behind an altered secretion are unclear. The purpose of this study is to investigate absorption and postprandial metabolism of glucose and protein in addition to gut hormonal responses after gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI. Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI, current BMI, sex and age will be included for comparison.

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Key information

Conditions

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

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre University Hospital

Hvidovre, Please Select, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

SG ang RYGB group:

Inclusion criteria

  • Uncomplicated RYGB or SG > 12 month prior to inclusion
  • Weight stable (+/- 3 month the last month)
  • Written informed consent

Exclusion criteria

  • Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
  • Pregnancy and/or breastfeeding
  • Inadequately treated thyroid disease
  • Serious heart or respiratory illness
  • Haemoglobin < 6,5 mM.

Un-operated control group:

Inclusion criteria

  • Written informed consent

Exclusion criteria

  • Prior RYGB, SG or complicated upper gastrointestinal surgery
  • Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
  • Pregnancy and/or breastfeeding
  • Inadequately treated thyroid disease
  • Serious heart or respiratory illness
  • Haemoglobin < 6,5 mM.

Treatment and study plan

Mixed meal test with double tracer technique

Diagnostic Test

Primary outcomes

  1. Glucose absorption

    Time frame: 0 - 360 minutes

    Between groups difference in peak Rate of appearance (Ra) of oral glucose tracer SG vs. CON

  2. Protein absorption

    Time frame: 0 - 360 minutes

    Between groups difference in peak Ra of oral aminoacid tracer SG vs. CON

Secondary outcomes

  1. Glucose absorption

    Time frame: 0 - 360 minutes

    Between group difference in peak Ra of oral glucose comparing SG vs. RYGB

  2. Protein absorption

    Time frame: 0 - 360 minutes

    Between groups differences in peak Ra of oral aminoacid tracer comparing SG vs. RYGB

  3. Glucose kinetics

    Time frame: 0 - 360 minutes

    Between groups differences in AUC Ra of oral glucose tracer

  4. Protein kinetics

    Time frame: 0 - 360 minutes

    Between groups differences in AUC Ra of oral aminoacid tracer

  5. Insulin secretion

    Time frame: 0 - 240 minutes

    Between groups differences in iAUC of serum insulin and C-peptide

  6. Glucagon-like Peptide 1 (GLP-1) secretion

    Time frame: 0 - 240 minutes

    Between groups differences in iAUC of plasma concentration of GLP-1

  7. Glucose-dependent Insulinotropic Peptide (GIP)

    Time frame: 0 - 240 minutes

    Between groups differences in iAUC of plasma concentration of GIP

  8. Ghrelin secretion

    Time frame: 0 - 240 minutes

    Between groups differences in iAUC of plasma concentration of ghrelin

  9. Glucagon secretion

    Time frame: 0-240 minutes

    Between groups differences in iAUC of plasma cncentration of glucagon

  10. Peptide YY

    Time frame: 0-240 minutes

    Between groups differences in iAUC of plasma concentration of PYY

  11. Endogenous glucose production

    Time frame: -120 - 360 minutes

    Calculated via double tracer tecnique both in the fasting and post prandial state.

  12. Lipolysis

    Time frame: -120 - 360

    Between groups differences in Rate of Disappearance of glycerol tracer.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

Effect of Gastric Sleeve Operation on Absorption and Metabolism of Glucose and Protein as Well as Gut-hormonal Response - A Comparison With Roux-en-Y Gastric Bypass

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 8, 2017
Registry last updated
Nov 30, 2020

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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