(1) To investigate the rate of glycaemic deterioration in subjects at high-risk of type 2 diabetes and with clinically manifest diabetes.(2) To identify biomarkers that define sub-classes of diabetes and thus enable targeted diabetes prevention or…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the rate of glycaemic deterioration in people with
type 2 diabetes and in people at high risk for type 2 diabetes, identifying
fast and slow deteriorators.
Secondary outcome
Not applicable.
Background summary
The phenotype of people who develop diabetes is highly variable, as is the rate
at which their subsequent diabetes progresses, how they respond to diabetes
therapy and who develops micro- and macrovascular complications. This
heterogeneity forms a major barrier to effective patient management at the
individual level. Type 2 diabetes is typified by a progressive deterioration in
glycaemic control with time. A reliable biomarker that can be used to predict
the trajectory of future glycaemic progression would help to identify subtypes
of diabetes and in particular could help to inform individualised therapeutic
selection and management.
Study objective
(1) To investigate the rate of glycaemic deterioration in subjects at high-risk
of type 2 diabetes and with clinically manifest diabetes.
(2) To identify biomarkers that define sub-classes of diabetes and thus enable
targeted diabetes prevention or treatment by identifying therapeutic targets
that are more prevalent in some subgroups of the studied population.
Study design
A prospective cohort study, with extensive follow-up examinations for 2
subgroups. 500 subjects at high-risk of type 2 diabetes will be participating
in study 1 and 167 subjects who are already diagnosed with type 2 diabetes will
be participating in study 2.
Study burden and risks
For the study, 1 to 5 visits to the DOC VUmc will take a total of 3 to 15
hours.
On the day of the visit the subjects are required to attend fasting since
22.00. During the visits the participants are asked to fill in some
questionnaires regarding medical history, quality of life, diet, physical
activity, sleeping behaviour and a screening for diastolic heartfailure. In
addition a physical examination including a sudoscan, anthropometry (height,
weight, waist / thigh / hip / calf circumference, blood pressure, % body fat),
blood collection and (in some of the subjects) a MRI scan will be performed.
Participants will undergo a mixed meal tolerance test or a glucose tolerance
test and toenail clipping. The subjects will also be asked to wear an
accelerometer for 10 days. Prior to the visit, participants are asked to
provide an urine and faecal sample.
Each visit a total amount of 10 to 79 ml blood will be collected. Blood
withdrawal can cause discomfort and can result in bruising that continues up to
a few days after the examinations. The glucose tolerance tests can lead to
nausea and vomiting. By participating in the study, new data on the health of
the subject can be detected (e.g. MRI).
In relation to the likelihood of injury, the severity of that injury and the
vulnerability of the participants we concluded that performing the current
research will result in a negligible risk for the participants and is therefore
justified.
van der Boechorstraat 7
Amsterdam 1081 BT
NL
van der Boechorstraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
All surviving subjects who participated in 2006 - 2008 in the New Hoorn Study, since 2003/2004 in the RISC study or in 2005 - 2006 in the Hoorn meal study will be invited for this study.;Additional recruitment of subjects diagnosed with type 2 diabetes (to reach targets for DIRECT Study 2): patients diagnosed with type 2 diabetes for > 3 months and < 24 months, management by lifestyle with or without metformin therapy, HbA1c < 7.6% within previous 3 months, white European, age > 35 and < 75y and eGFR > 50ml/min.;Participants also have to speak, read and write Dutch to participate.
Exclusion criteria
Overall: Inability to give written informed consent (for instance due to dementia).;Study 1 and 2: pregnancy, lactation or a female planning to conceive within the study period, any significant medical reason for exclusion as determined by the investigator, unable to give written informed consent, unable to speak, read and/or write Dutch.;Study 1: Diabetes of any type, treatment with insulin sensitizing, glucose lowering, or other anti-diabetic drugs, HbA1c > 6,5%.;Study 2: type 1 diabetes, a previous HbA1c > 9.0%, prior treatment with insulin or an OHA other than metformin, BMI < 20 or > 50 kg/m2.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40099.029.12 |