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Bileacid Malabsorption and GLP-1 Secretion

Primary Purpose

Bileacid Malabsorption

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
"cholestagel®" (Colesevelam)
Placebos
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bileacid Malabsorption

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Northern European origin
  • Normal haemoglobin
  • Age above 18 years and below 70 years
  • Informed and written consent
  • BMI > 23 kg/m2 and < 35 kg/m2
  • Normal fasting plasma glucose (FPG) < 6.5 mM) and glycated haemoglobin (HbA1c) < 48 mmol/mol

Exclusion Criteria:

  • Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
  • Gastrointestinal disease (except BAM), previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
  • First-degree relatives with diabetes
  • Nephropathy (serum creatinine >150 µM and/or albuminuria
  • Treatment with medicine that cannot be paused for 12 hours
  • Hypothyroidism or hyperthyroidism
  • Treatment with oral anticoagulants
  • Active or recent malignant disease
  • Any treatment or condition requiring acute or sub-acute medical or surgical intervention
  • Lack of effective birth control in premenopausal women
  • Any condition considered incompatible with participation by the investigators

Sites / Locations

  • Center for Diabetes Research, Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Healthy controls

Patients with BAM

Arm Description

Healthy controls found according to the protocol

Patients with bile acid malabsorption found according to the protocol

Outcomes

Primary Outcome Measures

GLP-1

Secondary Outcome Measures

Full Information

First Posted
December 21, 2016
Last Updated
August 4, 2017
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03009916
Brief Title
Bileacid Malabsorption and GLP-1 Secretion
Official Title
Bileacid Malabsorption and GLP-1 Secretion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
August 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

5. Study Description

Brief Summary
The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and glucose homeostasis, both with and without bile acid sequestration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bileacid Malabsorption

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
Other
Arm Description
Healthy controls found according to the protocol
Arm Title
Patients with BAM
Arm Type
Other
Arm Description
Patients with bile acid malabsorption found according to the protocol
Intervention Type
Drug
Intervention Name(s)
"cholestagel®" (Colesevelam)
Intervention Description
3750mg
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
3750mg
Primary Outcome Measure Information:
Title
GLP-1
Time Frame
240 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Northern European origin Normal haemoglobin Age above 18 years and below 70 years Informed and written consent BMI > 23 kg/m2 and < 35 kg/m2 Normal fasting plasma glucose (FPG) < 6.5 mM) and glycated haemoglobin (HbA1c) < 48 mmol/mol Exclusion Criteria: Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder Gastrointestinal disease (except BAM), previous intestinal resection, cholecystectomy or any major intra-abdominal surgery First-degree relatives with diabetes Nephropathy (serum creatinine >150 µM and/or albuminuria Treatment with medicine that cannot be paused for 12 hours Hypothyroidism or hyperthyroidism Treatment with oral anticoagulants Active or recent malignant disease Any treatment or condition requiring acute or sub-acute medical or surgical intervention Lack of effective birth control in premenopausal women Any condition considered incompatible with participation by the investigators
Facility Information:
Facility Name
Center for Diabetes Research, Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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Bileacid Malabsorption and GLP-1 Secretion

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