Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
Recruiting
Early Phase 1Interventional Study
Bariatric Surgery CandidateBile Acid, Elevated SerumGlucose Metabolism Disorders
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
18 (estimated)
Sponsor
Hvidovre University Hospital · Other
Who this trial is looking for
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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).
Trial Locations
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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 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
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