Treatment of Bile Acid Malabsorption With Liraglutide
- Conditions
- Bile Acid Malabsorption
- Interventions
- Registration Number
- NCT03955575
- Lead Sponsor
- Filip Krag Knop
- Brief Summary
Comparing the effect of Liraglutide on bile acid malabsorption, with colesevelam
- Detailed Description
The overall objective of the present study is to provide proof of concept that treatment with the GLP-1 receptor agonist liraglutide is efficacious (as assessed by symptom relief, i.e. response to treatment) and safe (as assessed by adverse effects) in the management of BAM and that it improves bile acid reabsorption (as assessed by SeHCAT) in these patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
-
• Caucasian ethnicity
- SeHCAT-verified moderate (5-10% bile acid retention after 7 days) or severe BAM (<5% retention)
- Normal haemoglobin (for men 8.3-10.5 mmol/L; for women 7.3-9.5 mmol/L)
- Age above 18 years and below 75 years
- Informed and written consent
- BMI >18,5 kg/m2 and <40 kg/m2
- Glycated haemoglobin (HbA1c) <48 mmol/mol
-
• History of or present hepatobiliary disorder (except for non-alcoholic steatotic liver disease) and/or alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3 times upper limit of normal) or history of hepatobiliary disorder
- Gastrointestinal disease (except for BAM), previous intestinal resection or any major intra-abdomial surgery
- Diabetes mellitus
- Nephropathy with eGFR < 60 mL/min/1.73m2
- Treatment with medicine that cannot be paused for 12 hours
- Hypothyroidism or hyperthyroidism, if not well regulated.
- Treatment with oral anticoagulants
- Active or recent malignant disease
- Any treatment or condition requiring acute or sub-acute medical or surgical intervention
- Females of child-bearing potential who is pregnant (tested before entering the study), breastfeeding or intend to become pregnant or is not using adequate contraceptive methods, which includes Intrauterine Device (IUD), birth control pills, sexual abstinence or living in a relationship with a sterile partner.
- Known or suspected hypersensitivity to trial products or related products
- Any condition considered incompatible with participation by the investigators
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liraglutide/placebo-colesevelam Liraglutide 6 MG/ML Liraglutide as active and colesevelam as placebo Placebo-Liraglutide/colesevelam Colesevelam Liraglutide as placebo and colesevelam as placebo
- Primary Outcome Measures
Name Time Method Change in stool fequency 7 weeks Contestants will use a questionaire, which will be filled out three times during the 7 weeks periode
- Secondary Outcome Measures
Name Time Method Change in SeHCAT 7 weeks Three SeHCAT scans will be made, and the difference will be evaluated
Total symptoms score, quality of life scores, and biomarker. 7 weeks Total symptoms score, quality of life scores, and biomarker values will be analysed using a constrained linear mixed model with inherent baseline adjustment and with an unstructured covariance pattern. Changes since baseline within and between groups will be reported with 95% confidence intervals.
Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea 7 weeks Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea within each group will be reported with exact binomial confidence intervals and compared between groups using risk differences and Fisher's exact test.
Trial Locations
- Locations (1)
Gentofte Hospital
🇩🇰Hellerup, Regionh, Denmark