Effects of Acetate on insulin Sensitivity, CNS regulation of food intake and appetite in Humans
- Conditions
- diabetesType 2 diabetes10018424
- Registration Number
- NL-OMON48359
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion criteria healthy lean subject group:
- Healthy Caucasian male or female
- Age 40-65
- Women must be post-menopausal
- BMI range of 19-25 kg/m²
- Subjects should be able and willing to give informed consent.
Inclusion criteria obese metabolic syndrome subject group:
- Caucasian male or female with metabolic syndrome
- Age 40-65
- Women must be post-menopausal
- BMI range of 25-40 kg/m²
- At least 3 out of 5 NCEP metabolic syndrome criteria: fasting plasma glucose
* 5.6 mmol/L and/or HOMA-IR * 2.5, triglycerides * 1.6 mmol/L,
waist-circumference > 102 cm, HDL cholesterol * 1.04 mmol/L, blood pressure *
130/85.
- Subjects should be able and willing to give informed consent.
Exclusion criteria for all participants:
- Systemic medication use, except for paracetamol
- Oral or intravenous antibiotics in the past 3 months before inclusion
- Smoking
- Substance abuse
- Excessive weight loss (> 10% in past 3 monts)
- Overt diabetes mellitus type 2
- Malignancy (except for basal cell carcinoma)
- History of major heart disease
- History of major renal disease
- Pregnancy or breast feeding
- Implantable devices
- Contra-indication for MRI, such as claustrophobia or pacemaker
- Psychiatric illnesses: mood disorders, eating disorders, anxiety disorders,
schizophrenia and other psychotic disorders, dissociative disorders, somatoform
disorders, delirium, dementia and other cognitive disorders
- Simultaneous participation in other studies
- Inability to understand the study protocol, give informed consent or
participate adequately in study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are the differences in postprandial glucose and<br /><br>insulin levels upon a standardized mixed meal test (SMMT) consisting of<br /><br>Nutridrink after acetate infusion.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secundary study parameters are postprandial incretins (GLP-1 and ghreline),<br /><br>insuline, glucose and lipid responses upon a SMM, subjective ratings of<br /><br>appetite in fasted state, after exposure to virtual food stimuli and upon a SMM<br /><br>and the CNS regulation of appetite upon virtual food stimuli and upon actual<br /><br>food stimuli (measured by both VAS questionnaire and functional MRI).</p><br>