Bileacid Malabsorption and GLP-1 Secretion
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 21, 2016
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2017
CompletedAugust 7, 2017
August 1, 2017
1.4 years
December 21, 2016
August 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
GLP-1
240 min
Study Arms (2)
Healthy controls
OTHERHealthy controls found according to the protocol
Patients with BAM
OTHERPatients with bile acid malabsorption found according to the protocol
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Diabetes Research, Gentofte Hospital
Hellerup, 2900, Denmark
Related Publications (1)
Karhus ML, Sonne DP, Thomasen M, Ellegaard AM, Holst JJ, Rehfeld JF, Chavez-Talavera O, Tailleux A, Staels B, Nielsen DS, Krych L, Dragsted LO, Vilsboll T, Bronden A, Knop FK. Enterohepatic, Gluco-metabolic, and Gut Microbial Characterization of Individuals With Bile Acid Malabsorption. Gastro Hep Adv. 2022 Mar 30;1(3):299-312. doi: 10.1016/j.gastha.2021.12.007. eCollection 2022.
PMID: 39131668DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 21, 2016
First Posted
January 4, 2017
Study Start
March 1, 2016
Primary Completion
August 3, 2017
Study Completion
August 4, 2017
Last Updated
August 7, 2017
Record last verified: 2017-08