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The effect of a bile acid sequestrant on bile acid- and glucose metabolism in patients with impaired glucose tolerance.


- candidate number5545
- NTR NumberNTR1745
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-apr-2009
- Secondary IDs2009-011972-31 EudraCT
- Public TitleThe effect of a bile acid sequestrant on bile acid- and glucose metabolism in patients with impaired glucose tolerance.
- Scientific TitleAltered Bile Acid Composition And Diabetes: Analysing Basic Relational Aspects; the ABACADABRA study.
- ACRONYMABACADABRA study
- hypothesisColesevelam is a bile sequestrant that not only improves lipid parameters, but also improves glycemic control. The workingsmechanismen of colesevelam is yet unknown. We hypothezize that treatment of obese insulin resistant subjects with colesevelam increases hepatic insulin sensitivity. In this study we want to investigate effect of colesevelam on bile acid composition, insulin resistance and glucose metabolism in patients with an impaired glucose tolerance or newly diagnosed type 2 diabetes.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Bile acid metabolism
- Inclusion criteria1. Male obese subjects with an impaired glucose tolerance or newly diagnosed type 2 diabetes mellitus (fasting glucose > 6,0 mmol/l);
2. Age 18-55 yr;
3. BMI>30 kg/m2.
- Exclusion criteria1. Medication known to interfere with glucose metabolism or bowel flora composition;
2. Severe hypertriglyceridemia or any other lipid metabolism disorder;
3. Intensive sports (> three times weekly).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2009
- planned closingdate1-mei-2011
- Target number of participants24
- InterventionsPatients will be randomised to either colesevelam treatment or placebo treatment for a period of 12 weeks.
- Primary outcomeThe primary endpoints are changes in bile acid composition.
- Secondary outcomeSecondary endpoints are changes in hepatic and peripheral insulin resistance (assessed by hyperinsulinemic euglycemic clamp at baseline and after 12 weeks), metabolic parameters (lipid profile, glycemic control) as well as changes in faecal microbiota, glucose and lipid content (assessed by analysing faeces samples). Finally, muscle and adipose tissue samples will be obtained to assess D2 mRNA and activity and phosphorylation status of the insulin signalling cascade.
- TimepointsBile acid metabolism will be measured before and after 12 weeks, using stable isotopes. Additionally insulin sensitivity is determined before and after 12 weeks by a two-step hyperinsulinemic euglycemic clamp using stable isotopes. Changes in liopid parameters/metabolic control and faecal flora composition will be determined before as well as after 4, 8 and 12 weeks after start of the trial.
- Trial web siteEudraCT
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A. Vrieze
- CONTACT for SCIENTIFIC QUERIESDrs. A. Vrieze
- Sponsor/Initiator Academic Medical Center (AMC), Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Internal Medicine
- PublicationsN/A
- Brief summaryObjective:
To investigate the effects of colesevelam (bile acid sequestrant) on bile acid composition, insulin resistance, glucose metabolism and composition of faecal flora in patients with an impaired glucose tolerance or newly diagnosed type 2 diabetes.
Study design:
Double blind randomized controlled single center trial.
Study Population:
Male obese subjects with an impaired glucose tolerance or newly diagnosed type 2 diabetes mellitus (fasting glucose > 6,0 mmol/l).
Treatment:
Patients will be randomised to either colesevelam treatment or placebo treatment for a period of 12 weeks.
Outcome measures:
The primary endpoints are changes in bile acid composition. Secondary endpoints are changes in hepatic and peripheral insulin resistance (assessed by hyperinsulinemic euglycemic clamp at baseline and after 12 weeks), metabolic parameters (lipid profile, glycemic control) as well as changes in faecal microbiota, glucose and lipid content (assessed by analysing faeces samples). Finally, muscle and adipose tissue samples will be obtained to assess D2 mRNA and activity and phosphorylation status of the insulin signalling cascade.
Powercalculation:
It is estimated that a total of 24 patients (12 patients per treatment arm) are needed to achieve statistical significant outcomes.
- Main changes (audit trail)
- RECORD3-apr-2009 - 23-sep-2009


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