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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02340247
Enrollment
11
Registered
2015-01-16
Start date
2014-11-30
Completion date
Unknown
Last updated
2016-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Obesity

Brief summary

The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.

Interventions

OTHERWater
DRUGUrsodeoxycholic Acid
DRUGChenodeoxycholic Acid

Sponsors

University of Copenhagen
CollaboratorOTHER
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
GLP-1 secretion (evaluated by iAUC)Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

Secondary

MeasureTime frame
PYY secretion (evaluated by iAUC)Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Glucagon secretion (evaluated by iAUC)Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
GIP secretion (evaluated by iAUC)Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
CCK secretion (evaluated by iAUC)Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
C-peptide secretion (evaluated by iAUC)Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Changes in bile acids/FGF-19Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
TSH/T3/T40, 60, 120, 180
Appetite measurements (VAS-score)Baseline, 30, 60, 120, 180
Gherlin secretion (evaluated by iAUC)Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026