Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery

NCT06925997 | Recruiting Early Phase 1 DMC

• 1 other identifier: H-22041713
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Bariatric Surgery Candidate; Bile Acid, Elevated Serum; Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (2)

• Glucose

  Changes in total areal under the curve (AUC) of plasma glucose concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).

  8 weeks

• FGF-19

  Changes in total AUC of plasma FGF-19 concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).

  8 weeks

Other Outcomes (12)

• Explorative outcomes, glucose

  8 weeks

• Explorative outcomes, Bile acids

  8 weeks

• Explorative outcomes, FGF-19

  8 weeks

Study Arms (1)

3.75 mg Colesevelam in 8 weeks

EXPERIMENTAL

Drug: Colesevelam

Interventions

Colesevelam DRUG

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 systemic circulation, i.e. treatment effects cease when the drug is excreted from the intestine. Specifically, no permanent metabolic effects of colesevelam has been observed in crossover experiments (27). Therefore, 8 weeks of colesevelam treatment as planned in the current study will have no long lasting positive or negative effects on the participants.

3.75 mg Colesevelam in 8 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intervention group
• 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
• Control group A
• No history of diabetes

You may not qualify if:

• Pregnancy or breastfeeding
• Prior cholecystectomy
• Chronic or tendency to diarrhoea

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Central Study Contacts

Marie-Louise Dichman

CONTACT

+4526710371; marie-louise.dichman@regionh.dk

Carsten Dirksen

CONTACT

carsten.dirksen@regionh.dk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, Ph.D. student

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 13, 2025
• Study Start: May 2, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

DK (1)