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Completed

NCT Number: NCT02876484

Effects of Bile Acids and Bile Acid Sequestrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

The purpose of this study is to examine the effects of bile acid and bile acids sequestrants on GLP-1 Secretion, during a meal, in patients after Roux-en-Y gastric bypass.

Completed

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre University Hospital

Hvidovre, DK-2650, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Uncomplicated RYGB performed minimum 3 months prior to the study.
  • Fasting plasma glucose < 7,0 mM, HbA1c < 48 mmol/mol 3 months after RYGB

Exclusion criteria

  • Fasting plasma glucose > 7,0 mM, HbA1c > 48 mmol/mol 3 months after RYGB.
  • Dysregulated thyroid diseases, use of antithyroid treatment.
  • Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.
  • Complications to RYGB. Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake).
  • Cholecystectomy

Treatment and study plan

Colesevelam

Drug

Chenodeoxycholic Acid

Drug

Water

Other

Primary outcomes

  1. GLP-1 secretion (evaluated by iAUC)

    Time frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes after mixed meal

Secondary outcomes

  1. Glucose levels

    Time frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

  2. Insulin secretion

    Time frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

  3. PYY secretion

    Time frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

  4. Bile acids/FGF19 concentrations

    Time frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

  5. Appetite measurements (VAS-score)

    Time frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

  6. PCM levels

    Time frame: Baseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes

  7. C-peptide secretion

    Time frame: Baseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes

  8. Glucagon secretion

    Time frame: Baseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes

  9. GIP secretion

    Time frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

  10. CCK secretion

    Time frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

  11. Ghrelin

    Time frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

  12. Total bile acid secretion

    Time frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

Effects of Chenodeoxycholic Acid and Colesevelam on GLP-1 Secretion, During a Meal, After Roux-en-Y Gastric Bypass

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Aug 23, 2016
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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