NCT02340247

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

January 13, 2015

Last Update Submit

June 29, 2016

Conditions

Severe Obesity

Outcome Measures

Primary Outcomes (1)

  • GLP-1 secretion (evaluated by iAUC)

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

Secondary Outcomes (9)

  • C-peptide secretion (evaluated by iAUC)

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

  • 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

  • +4 more secondary outcomes

Study Arms (3)

Placebo

EXPERIMENTAL

150mL water

Other: Water

Ursodeoxycholic acid

EXPERIMENTAL

Ursodeoxycholic acid (750mg) dissolved in 150mL water

Drug: Ursodeoxycholic Acid

Chenodeoxycholic acid

EXPERIMENTAL

Chenodeoxycholic acid (1250mg) dissolved in 150mL water

Drug: Chenodeoxycholic Acid

Interventions

WaterOTHER
Placebo
Ursodeoxycholic AcidDRUG
Ursodeoxycholic acid
Chenodeoxycholic AcidDRUG
Chenodeoxycholic acid

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Uncomplicated RYGB performed minimum 3 months prior to the study.
  • Fasting plasma glucose \< 7.0mM, HbA1c \< 48mmol/mol 3 months after RYGB.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, DK-2650, Denmark

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

WaterUrsodeoxycholic AcidChenodeoxycholic Acid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsDeoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

November 1, 2014

Primary Completion

April 1, 2015

Last Updated

June 30, 2016

Record last verified: 2016-06

Locations

DK(1)