Effect of Bile Acid Sequestration on Postprandial GLP-1 Secretion, Glucose Homeostasis and Gut Microbiota
NCT ID: NCT02061124
Last Updated: 2015-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2014-02-28
2015-10-31
Brief Summary
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The current study is a human interventional study with 7-day ingestion of a bile acid sequestrant or placebo, preceded and followed by meal tests and faecal sampling. The aim is to examine how (and if) bile acid sequestration can influence postprandial glucagon-like peptide-1 (GLP-1) secretion, gut microbiota and glucose homeostasis in patients with type 2 diabetes and healthy individuals. As a tool to sequester bile acids we will use sevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adult patients with chronic kidney disease. Surprisingly, sevelamer was recently shown to improve glycaemic control in patients with chronic kidney disease and type 2 diabetes.
The investigators hypothesize that higher luminal concentrations of bile acids in the distal gut will elicit changes in the postprandial gut hormone secretion and gut bacteria composition. The current study will help to clarify this hypothesis and improve our general understanding of the association between bile acid circulation and signalling, gut hormone secretion, gut bacteria and glucose metabolism.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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T2DM, sevelamer
Patients with type 2 diabetes treated with sevelamer
Sevelamer 1600 mg TID for 7 days
T2DM, placebo
Patients with type 2 diabetes treated with placebo
Placebo 1600 mg TID for 7 days
Healthy subjects, sevelamer
Healthy subjects treated with sevelamer
Sevelamer 1600 mg TID for 7 days
Healthy subjects, placebo
Healthy subjects treated with placebo
Placebo 1600 mg TID for 7 days
Interventions
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Sevelamer 1600 mg TID for 7 days
Placebo 1600 mg TID for 7 days
Eligibility Criteria
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Inclusion Criteria
* Caucasian ethnicity
* Normal haemoglobin
* Age above 35 years and below 80 years
* Informed and written consent
* BMI \> 23 kg/m2 and \<35 kg/m2
Patients with type 2 diabetes
* Type 2 diabetes for at least 3 months
* Diagnosed according to the criteria of the World Health Organization (WHO)
Healthy Subjects
* Normal fasting plasma glucose (FPG) \<6.5 mM and
* Normal glycated haemoglobin (HbA1c) \<6.0 %
Exclusion Criteria
* Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary disorder
* Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
* Hypo- or hyperphosphataemia
* Nephropathy (serum creatinine \>150 µM and/or albuminuria
* Treatment with medicine that cannot be paused for 12 hours
* Intake of antibiotics six months prior to study
* Hypo- or hypercalcaemia
* Hypo- and 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
* Positive pregnancy test on study days in premenopausal women
* Tobacco smoking
* Any condition considered incompatible with participation by the investigators
Patients with type 2 diabetes
* Treatment with insulin
* Treatment with incretin-based therapy
Healthy Subjects
* Diabetes or
* prediabetes (fasting plasma glucose levels \>6.5 mM or HbA1c \>6.0%)
* First-degree relatives with diabetes
35 Years
80 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
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Andreas Brønden
MD
Locations
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Diabetes Research Division, Gentofte Hospital, Copenhagen
Hellerup, , Denmark
Countries
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Other Identifiers
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H-2-2013-148
Identifier Type: -
Identifier Source: org_study_id