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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02876484
Enrollment
12
Registered
2016-08-23
Start date
2016-06-30
Completion date
2020-11-30
Last updated
2020-11-30

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 acid and bile acids sequestrants on GLP-1 Secretion, during a meal, in patients after Roux-en-Y gastric bypass.

Interventions

DRUGColesevelam
DRUGChenodeoxycholic Acid
OTHERWater

Sponsors

University of Copenhagen
CollaboratorOTHER
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Uncomplicated RYGB performed minimum 3 months prior to the study. * Fasting plasma glucose \< 7,0 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

Design outcomes

Primary

MeasureTime frame
GLP-1 secretion (evaluated by iAUC)-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes after mixed meal

Secondary

MeasureTime frame
Insulin secretion-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
PYY secretion-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Bile acids/FGF19 concentrations-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Appetite measurements (VAS-score)0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
PCM levelsBaseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes
Glucose levels-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Glucagon secretionBaseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
GIP secretion0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
CCK secretion0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Ghrelin0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Total bile acid secretion0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
C-peptide secretionBaseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes

Countries

Denmark

Outcome results

None listed

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