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Completed

NCT Number: NCT02879955

Carbohydrates and Gut Hormones After Gastric Bypass Surgery

To investigate the secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1), after ingestion of glucose and fructose as separate monosaccharides or combined in the disaccharides sucrose and isomaltulose and the effect of acarbose in gastric bypass operated subjects and BMI-matched controls.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Endocrinology

Hvidovre, 2650, Denmark

About this study

Disaccharides such as sucrose or isomaltulose (also called palatinose) require digestion into monosaccharides (both are digested to glucose and fructose) by enzymes located in the brush border of the small intestine to be absorbed. The study will investigate the influence of carbohydrate digestion on gut hormone secretion.

Who can participate

Healthy volunteers accepted: Yes

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

Gastric bypass operated patients:

Inclusion criteria

  • uncomplicated gastric bypass surgery performed minimum 12 months prior to study

Exclusion criteria

  • Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
  • Pregnancy or breastfeeding
  • Haemoglobin levels below 6,5 mM

Healthy control subjects:

Exclusion criteria

  • Bariatric surgery or complicated upper abdominal surgery
  • Pregnancy or breastfeeding
  • Haemoglobin levels below 6,5 mM
  • Co-morbidities or medicine significantly affecting glucose metabolism or appetite regulation

Treatment and study plan

Glucose + Fructose

Other

Ingestion of the separate monosaccharides glucose (25 g) and fructose (25 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Sucrose

Other

Ingestion of the disaccharide sucrose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Isomaltulose

Other

Ingestion of the slowly digestable disaccharide isomaltulose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Sucrose + Acarbose

Other

Ingestion of the disaccharide sucrose (47.5 g) and the alpha glucosidase inhibitor acarbose dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Primary outcomes

  1. Within group difference in GLP-1 secretion (evaluated by iAUC).

    Time frame: 0-240 min following carbohydrate ingestion

    Comparison of the GLP-1 responses (evaluated by iAUC) induced by the different carbohydrate loads.

Secondary outcomes

  1. Between group comparison of GLP-1 secretion (evaluated by iAUC).

    Time frame: 0-240 min following carbohydrate ingestion

    GLP-1 secretion (evaluated by iAUC) in gastric bypass operated patients compared to BMI-matched control subjects for each of the carbohydrate loads.

  2. Between group comparison of differences in GLP-1 secretion (evaluated by iAUC).

    Time frame: 0-240 min following carbohydrate ingestion

    Differences in GLP-1 secretion (evaluated by iAUC) induced by the different carbohydrate loads in gastric bypass operated patients compared to differences in BMI-matched control subjects.

  3. Responses (evaluated by iAUC) of glucose within and between groups.

    Time frame: 0-240 min following carbohydrate ingestion

  4. Responses (evaluated by iAUC) of insulin within and between groups.

    Time frame: 0-240 min following carbohydrate ingestion

  5. Responses (evaluated by iAUC) of C-Peptide within and between groups.

    Time frame: 0-240 min following carbohydrate ingestion

  6. Responses (evaluated by iAUC) of peptide YY (PYY) within and between groups.

    Time frame: 0-240 min following carbohydrate ingestion

  7. Responses (evaluated by iAUC) of Gastric Inhibitory Peptide (GIP) within and between groups.

    Time frame: 0-240 min following carbohydrate ingestion

  8. Responses (evaluated by iAUC) of glucagon within and between groups.

    Time frame: 0-240 min following carbohydrate ingestion

  9. Responses (evaluated by iAUC) of oxyntomodulin within and between groups.

    Time frame: 0-240 min following carbohydrate ingestion

  10. Responses (evaluated by iAUC) of cholecystokinin (CCK) within and between groups.

    Time frame: 0-240 min following carbohydrate ingestion

  11. Responses (evaluated by iAUC) of bile acids within and between groups.

    Time frame: 0-240 min following carbohydrate ingestion

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

Effects of Carbohydrates on Gut Hormone Secretion After Gastric Bypass Surgery

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 26, 2016
Registry last updated
Jul 19, 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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