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Completed

NCT Number: NCT02340247

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

The purpose of this study is to examine the effects of bile acids on GLP-1 secretion 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 < 7.0mM, HbA1c < 48mmol/mol 3 months after RYGB.

Exclusion criteria

  • Fasting plasma glucose > 7.0mM, HbA1c > 48mmol/mol 3 months after RYGB.
  • Dysregulated hypothyroidism, 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).

Treatment and study plan

Water

Other

Ursodeoxycholic acid

Drug

Chenodeoxycholic Acid

Drug

Primary outcomes

  1. GLP-1 secretion (evaluated by iAUC)

    Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

Secondary outcomes

  1. C-peptide secretion (evaluated by iAUC)

    Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

  2. PYY secretion (evaluated by iAUC)

    Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

  3. Glucagon secretion (evaluated by iAUC)

    Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

  4. GIP secretion (evaluated by iAUC)

    Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

  5. CCK secretion (evaluated by iAUC)

    Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

  6. Gherlin secretion (evaluated by iAUC)

    Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

  7. Changes in bile acids/FGF-19

    Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

  8. TSH/T3/T4

    Time frame: 0, 60, 120, 180

  9. Appetite measurements (VAS-score)

    Time frame: Baseline, 30, 60, 120, 180

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Important dates

Study start
2014
Primary completion
2015
First posted
Jan 16, 2015
Registry last updated
Jun 30, 2016

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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