Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colesevelam.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Candidate, Bile Acid, Elevated Serum, Glucose Metabolism Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (FGF-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (RYGB).
Detailed description
The study design consists of 4 study visits, two performed before (V1 at day -7 and V2 at day 0 relative to initiation colesevelam treatment) and two after approximately 8 weeks of colesevelam treatment (V3 at day 49 and V4 at day 56). Biometrics, fasting blood samples and a standard mixed meal test are performed at V2 and V4. 75Se-HCAT scintigraphy is carried out between V1 to V2 and V3 to V4, respectively. Between V2 and V3 the subjects will have two telephone calls and one visit at the Endocrine Research Unit for fasting blood samples to make sure they do not experience any adverse events and are compliant.
The control groups will only participate in V1 and V2. The aim with the control groups is to have baseline values for unoperated subjects with and without diabetes to compare with the values in the intervention group after 8 weeks of depletion of endogenous bile acids.
Interventions
- Drug Colesevelam
Colesevelam is an approved drug with well known adverse events. Gastrointestinal side effects (Obstipation, flatulence, abdominal pain, diarrhea, nausea, meteorism, vomiting, chanced faeces) are very common (\>10%) or common (1-10%), but are mild and tolerable in most cases. All participants will be monitored closely, and colesevelam will be discontinued if the subject experience unreserved adverse events. All effects of colesevelam are transient (17-19) as the compound is not absorbed to the sy
Primary outcome measures
- Glucose [Time frame: 8 weeks]
- FGF-19 [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
Intervention group
- RYGB-operated ≥ 18 months prior to inclusion
- History of diabetes prior to RYGB (HbA1c ≥48 mmol/mol or use of antidiabetic medication)
- HbA1c <58 mmol/mol on no antidiabetic medication or metformin alone
- Weight change < ±3 kg for >3 months at time of inclusion
Control group A
- No history of diabetes
- HbA1c <48 mmol/mol at time of inclusion
- Fasting plasma glucose < 7.0 mmol/L at time of inclusion
- Weight change < ±3 kg for >3 months at time of inclusion Control group B
- Type 2 diabetes (HbA1c ≥48 mmol/mol or use of antidiabetic medication at time of inclusion)
- Weight change < ±3 kg for >3 months at time of inclusion
Exclusion criteria
- Pregnancy or breastfeeding
- Haemoglobin < 6.5 mmol/L at time of inclusion
- Fasting plasma glucose > 10.0 mmol/L at time of inclusion
- Prior cholecystectomy
- Chronic or tendency to diarrhoea
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre — Hvidovre
Identifiers
NCT: NCT06925997 · H-22041713