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Effects of Acetate on insulin Sensitivity, CNS regulation of food intake and appetite in Humans

Effects of Acetate on insulin Sensitivity, CNS regulation of food intake and appetite in Humans - AISCHA study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48359
Enrollment
60
Registered
2019-12-17
Start date
2020-10-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes Type 2 diabetes

Interventions

All participants will receive either 1700 mL of sodium acetate with a concentration of 150 mmol/L or sodium bicarbonate with a concentration of 150 mmol/L administered intravenously over a period of

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The main study parameters are the differences in postprandial glucose and insulin levels upon a standardized mixed meal test (SMMT) consisting of Nutridrink after acetate infusion.

Secondary

MeasureTime frame
The secundary study parameters are postprandial incretins (GLP-1 and ghreline), insuline, glucose and lipid responses upon a SMM, subjective ratings of appetite in fasted state, after exposure to virtual food stimuli and upon a SMM and the CNS regulation of appetite upon virtual food stimuli and upon actual food stimuli (measured by both VAS questionnaire and functional MRI).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 3, 2026