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The physiological role of bile acid‐mediated glucagon‐like peptide‐1 release in humans: The Cerebrotendinous Xanthomatosis Mixed Meal Test study.


- candidate number9014
- NTR NumberNTR2723
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jan-2011
- Secondary IDs2011_036 MEC AMC
- Public TitleThe physiological role of bile acid‐mediated glucagon‐like peptide‐1 release in humans: The Cerebrotendinous Xanthomatosis Mixed Meal Test study.
- Scientific TitleThe physiological role of bile acid‐mediated glucagon‐like peptide‐1 release in humans: The Cerebrotendinous Xanthomatosis Mixed Meal Test study.
- ACRONYM
- hypothesisWe hypothesize that CTX patients, when untreated for a short period, differ from matched healthy controls in the response to a test meal. CTX patients are expected to have lower postprandial GLP‐1 and insulin levels with higher plasma glucose and FFA levels.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Insulin resistance
- Inclusion criteriaInclusion criteria, CTX patients:
1. Adult age (older than 18 years of age);
2. Body mass index 19‐30 kg/m2;
3. General good health (normal liver and renal function);
4. HbA1c below 7%;
5. Ability to give informed consent.

Inclusion criteria, matched controls:
Matched to CTX patients on individual basis. Preferably, these controls are unaffected healthy relatives to prevent differences in environmental factors (diet, faecal microbial composition, activity). If this is not possible, healthy matched control (age, length, height, gender) will be recruited.
- Exclusion criteriaSince CTX is a rare disorder, little exclusion criteria exist. However, patients that use medication that interferes with glucose metabolism such as oral antidiabetic medication or insulin are not included.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2011
- planned closingdate1-apr-2012
- Target number of participants28
- InterventionsMixed meal test: Liquid meal test (standard protocol) during which blood withdrawals are taken for 2-4 hours to measure glucose, insulin, bile acids and incretins.
- Primary outcomeGlucose, bile acids and incretins during meal test.
- Secondary outcomeEnergy expenditure.
- TimepointsOne occoasion, 3hr meal test.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. M.R. Soeters
- CONTACT for SCIENTIFIC QUERIESMD. M.R. Soeters
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryBile acids (BAs) have traditionally been regarded as nutrient‐emulgators but may play an important role in energy metabolism. Primary bile acids are secreted in the bile and are dehydroxylated by the bacterial flora in the colon to form the secondary bile acids. BAs may stimulate the production of glucagon‐like peptide‐1 (GLP‐1) that stimulates insulin secretion and inhibits glucagon secretion in the pancreas in a glucose‐dependent fashion. Additionally, it reduces gastrointestinal motility and appetite. Cerebrotendinous xanthomatosis (CTX, OMIM #213700) is an autosomal recessive disorder characterized by a deficiency of sterol 27‐hydroxylase leading to a defective BA synthesis (decreased amount of the BA chenodeoxycholate (CDCA)). It is not known whether CTX patients exhibit physiological deficiencies with regard to postprandial plasma GLP‐1 responses, glucose uptake, free fatty acid (FFA) suppression and plasma insulin levels. Studying postprandial glucose metabolism in these patients will provide insight in the metabolic role of BAs. We hypothesize that CTX patients, when untreated, have lower postprandial GLP‐1 and insulin levels with higher plasma glucose and FFA levels compared to matched healthy control subjects.
Thus, the primary aim of the present protocol is to determine the role of chenodeoxycholate for postprandial GLP‐1 responses (and the resulting metabolic consequences) in humans.
- Main changes (audit trail)
- RECORD24-jan-2011 - 14-feb-2011


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