Bileacid Malabsorption and GLP-1 Secretion

Overview

The aim of this study is to examine the influence of BAM on postprandial GLP–1 secretion and glucose homeostasis, both with and without bile acid sequestration.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 3, 2017

Interventions

  • Drug: “cholestagel®” (Colesevelam)
    • 3750mg
  • Drug: Placebos
    • 3750mg

Arms, Groups and Cohorts

  • Other: Healthy controls
    • Healthy controls found according to the protocol
  • Other: Patients with BAM
    • Patients with bile acid malabsorption found according to the protocol

Clinical Trial Outcome Measures

Primary Measures

  • GLP-1
    • Time Frame: 240 min

Participating in This Clinical Trial

Inclusion Criteria

  • Northern European origin – Normal haemoglobin – Age above 18 years and below 70 years – Informed and written consent – BMI > 23 kg/m2 and < 35 kg/m2 – Normal fasting plasma glucose (FPG) < 6.5 mM) and glycated haemoglobin (HbA1c) < 48 mmol/mol Exclusion Criteria:

  • Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder – Gastrointestinal disease (except BAM), previous intestinal resection, cholecystectomy or any major intra-abdominal surgery – First-degree relatives with diabetes – Nephropathy (serum creatinine >150 µM and/or albuminuria – Treatment with medicine that cannot be paused for 12 hours – Hypothyroidism or hyperthyroidism – Treatment with oral anticoagulants – Active or recent malignant disease – Any treatment or condition requiring acute or sub-acute medical or surgical intervention – Lack of effective birth control in premenopausal women – Any condition considered incompatible with participation by the investigators

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Gentofte, Copenhagen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Filip Krag Knop, Professor – University Hospital, Gentofte, Copenhagen

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