The main objective of this study is to determine whether prediabetic individuals and those already diagnosed with type 2 diabetes show differences in sweet taste perception and whether this difference is related to their oral and/or gut microbiota…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters/endpoints:
* Differences between control and diabetes patients in:
o sweet detection threshold
o composition and diversity of the oral and gut microbiota
Secondary outcome
Secondary study parameters/endpoints:
* Differences between control and diabetes patients in:
o metabolic response to sweet by the gut
o the ways in which the above three parameters (sweet detection threshold,
microbiota and metabolic response) relate to each other
Background summary
Diabetes is a worldwide problem with a heavy burden on healthcare costs and it
is associated with a variety of complications. Previous research has shown that
people with type 2 diabetes may have altered mechanisms of nutrient sensing,
which interferes with the response of the body via metabolic, endocrine and
neural changes. Nutrient sensing starts in the mouth and is then continued in
the gut by taste perception via receptors. The detection of sweet taste
determines metabolic responses such as glucose homeostasis and satiety hormone
release. Alterations of these functions can contribute to the onset of diabetes
and obesity. The oral and gut microbiota interacts with host metabolism and
physiology in many different and complex ways, and is likely to play a role in
nutrient sensing, taste detection and regulation of appetite.
Study objective
The main objective of this study is to determine whether prediabetic
individuals and those already diagnosed with type 2 diabetes show differences
in sweet taste perception and whether this difference is related to their oral
and/or gut microbiota composition. The secondary objective of this study is to
investigate to what extent oral and/or gut nutrient sensing of sweet impacts
the entero-endocrine response.
Study design
The study will consist of two phases. In phase I, data on oral sweet taste
perception and on oral and gut microbiota will be collected from a cohort of
participants with type 2 diabetes (n=50), age and gender matched with
non-diabetic controls (n = 50). In phase II, a subset of these participants (n
= 20; 10 diabetes patients & 10 non-diabetic controls) will receive a mixed
meal challenge in combination with oral or gastrointestinal priming with a
sweetener or water, to determine the relation between nutrient sensing in the
mouth and gut and the metabolic response of the gut.
Intervention
Phase I study: not applicable. Phase II study: steviol glycosides are
administered to both groups.
Study burden and risks
We do not foresee specific risks for the participants in the study.
Participants will be asked to visit the research centre once for phase I of the
study, during which anthropometric measures and a taste detection threshold
will be measured using non-invasive procedures. In Phase II participants will
be asked to visit the centre three times, and each time blood will be
collected. The remaining samples will be obtained through non-invasive
procedures (faeces collection and buccal/tongue swab).
Utrechtseweg 48
Zeist 3700 AJ
NL
Utrechtseweg 48
Zeist 3700 AJ
NL
Listed location countries
Age
Inclusion criteria
* Able to speak, write and understand Dutch
* Voluntary participation
* Provided written informed consent
* Willing to comply with the study procedures of phase 1 and phase 2
* Appropriate veins and circulation for blood sampling
* Willing to accept use of all nameless data, including publication(s), and the confidential use and storage of all data for at least 15 years
* Willing to accept the disclosures of the financial benefit of participation in the study to the authorities concerned
Exclusion criteria
* Any significant medical reason for exclusion as determined by the investigator
* Having a history of medical or surgical (gastrointestinal) events that may significantly affect the study outcome
* Smoking
* Other medication for diabetes than oral medication (i.e. Insulin)
* Recent antibiotic medication (in the last 3 months)
* Alcohol consumption > 21 units/week
* Unable to give written informed consent
* Not willing to give up blood donation during the study
* Not having a general practitioner
* Not willing to accept information transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63702.029.17 |
| OMON | NL-OMON27844 |