BridgeMD
New treatment option for Bariatric Surgery Candidate
Official title Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
ClinicalTrials.gov ID: NCT06925997
What this study is testing
What is Colesevelam?
Colesevelam is an investigational medicine, being studied as a potential treatment for bariatric surgery candidate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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 months at time of inclusion Control group A
You likely can't join if
- 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
See the full eligibility 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 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 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 months at time of inclusion
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hvidovre, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hvidovre, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.