Research with human participants

Overview of medical research in the Netherlands

Het effect van een hoog-vet dieet op galzouten in het bloed.

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Ethical review
Positive opinion
Status
Recruiting
Health condition type
-
Study type
Interventional

ID

NL-OMON25160

Source

NTR

Brief title

BAM2

Health condition

Obesity, Diabetes Mellitus type 2.

Sponsors and support

Primary sponsor :
Academisch Medisch Centrum Amsterdam
Source(s) of monetary or material Support :
Diabetes Fonds

Intervention

Outcome measures

Primary outcome

postprandial bile acid concentrations in plasma

Secondary outcome

postprandial insulin and glucose concentrations in plasma, resting energy expenditure

Study objective

Bile acids are pleiotropic hormones with actions on energy expenditure and insulin sensitivity in animal models. A high-fat diet that affects insulin sensitivity could modulate postprandial bile acid concentrations in plasma, leading to downstream effects on insulin sensitivity through its receptors FXR and TGR5.

Study design

0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 240

Intervention

High fat eucaloric diet (>90 energy% from fats)

Public
Academic Medical Center (AMC)<br>
Department of Endocrinology & Metabolism, F5-162<br>
P.O. Box 22660
M.R. Soeters
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
m.r.soeters@amc.uva.nl
Scientific
Academic Medical Center (AMC)<br>
Department of Endocrinology & Metabolism, F5-162<br>
P.O. Box 22660
M.R. Soeters
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
m.r.soeters@amc.uva.nl

Inclusion criteria

BMI > 30

HOMA IR index < 2.7

Exclusion criteria

Diabetes Mellitus

Medication use

History of gastrointetinal surgery

History of metabolic disease

Design

Study type :
Interventional
Intervention model
:
Crossover
Allocation :
Non controlled trial
Masking :
Open (masking not used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
12
Type :
Anticipated

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

ID: 41585
Bron: ToetsingOnline
Titel: Postprandial bile acid metabolism in insulin sensitive and insulin resistant subjects:
The Bile Acid Study

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL5696
NTR-old NTR5848
CCMO NL41901.018.12
OMON NL-OMON41585