Type 2 Diabetes Clinical Trial
Official title:
The Impact of the P4 Approach, Preventive, Predictive, Personalized and Participatory in Newly Diagnosed Type 2 Diabetics in Hillegom
The study aims to assess the impact of the P4 approach on established markers of glucose
metabolism in type 2 diabetics.
Secondary objectives are examination of the changes in physical characteristics, quality of
life and the indices for beta cell function, hepatic insulin resistance and muscle insulin
resistance .
This study will be a proof-of-principle exploratory study. Subjects in the P4 program will
receive a personalized diagnosis and treatment. After investigation of the status of the
different organs involved in diabetes (liver, muscle, pancreas), subjects in the P4 group are
divided into 3 subgroups. Each subgroup receives a personalized lifestyle advice. This
lifestyle advice may comprise different interventions, i.e. very low calorie diet, low
calorie diet, strength training, endurance training. Dependent on the type of intervention,
these interventions will be supervised by a dietitian or physiotherapist.
All subjects will visit a central study center 5 times during the study and 3 times during
follow-up. During these visits physical measures will be taken and data will be collected by
the general practitioner assistant.
After the three month intervention period the subjects will return to usual care via the
general practitioner.
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