NCT02876484

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2016

Longer than P75 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

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

July 1, 2016

Last Update Submit

November 25, 2020

Conditions

Severe Obesity

Outcome Measures

Primary Outcomes (1)

  • GLP-1 secretion (evaluated by iAUC)

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

Secondary Outcomes (12)

  • Glucose levels

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

  • 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

  • +7 more secondary outcomes

Study Arms (4)

Placebo

EXPERIMENTAL

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. 25 ml water

Other: Water

Chenodeoxycholic Acid

EXPERIMENTAL

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Chenodeoxycholic acid (1250 mg) mixed in 25 ml yoghurt

Drug: Chenodeoxycholic Acid

Colesevelam

EXPERIMENTAL

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.

Drug: Colesevelam

Colesevelam x 2

EXPERIMENTAL

plus (on another study day) 3,75 g colesevelam administered the evening before the experiment. Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.

Drug: Colesevelam

Interventions

ColesevelamDRUG
ColesevelamColesevelam x 2
Chenodeoxycholic AcidDRUG
Chenodeoxycholic Acid
WaterOTHER
Placebo

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 \< 7,0 mM, HbA1c \< 48 mmol/mol 3 months after RYGB

You may not qualify if:

  • 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

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

Colesevelam HydrochlorideChenodeoxycholic AcidWater

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AllylamineAminesOrganic ChemicalsAllyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsDeoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

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

Study Record Dates

First Submitted

July 1, 2016

First Posted

August 23, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

November 1, 2020

Last Updated

November 30, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Locations

DK(1)