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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
60
subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice
subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.
subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.
Huisartsenpraktijk Lommelaars
Hillegom, South Holland, Netherlands
Huisartspraktijk C.C. Dekker
Hillegom, South Holland, Netherlands
Huisartspraktijk Tubbergen
Hillegom, South Holland, Netherlands
Change in HbA1c levels
Changes in primary outcome measures will be determined by using a mixed model
Time frame: In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months
Change in 2h glucose levels
2h glucose will be measured after Oral Glucose Tolerance Test (OGTT). Changes in primary outcome measures will be determined by using a mixed model
Time frame: In-study at week 0 (baseline) and 13;
Change in fasting blood glucose levels
After 8 hour fasting. Changes in primary outcome measures will be determined by using a mixed model.
Time frame: In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months
percentage of participants that reach normoglycemia
normoglycemia is determined by fasting blood glucose level of less than 6.1 mmol/L
Time frame: end of study (after 13 weeks)
body weight
measured by the general practitioner assistant
Time frame: screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months
blood pressure
measured by the general practitioner assistant
Time frame: screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months
waist circumference
measured by general practitioner assistant
Time frame: screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months
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Huisartsenpraktijk Sixlaan 9
Hillegom, South Holland, Netherlands
Huisartsenpraktijk J.G. van Dusseldorp
Hillegom, South Holland, Netherlands
Huisartsenpraktijk van der Kaaden
Hillegom, South Holland, Netherlands
Huisartsenpraktijk Elsbroek
Hillegom, South Holland, Netherlands
Huisartsenpraktijk Mulders
Hillegom, South Holland, Netherlands
Netherlands Organisation for Applied Scientific Research (TNO)
Zeist, Utrecht, Netherlands
body fat percentage
measured by general practitioner assistant
Time frame: screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months
change indices for muscle insulin resistance
at week 0 and 13 the indices will be calculated from Oral glucose tolerance test data. Blood will be collected at the blood collection centre in Hillegom
Time frame: screening; in-study at week 0 and 13;
health behaviour change
established by comparing baseline values with end of study values for food intake and physical activity as measured by a Lifestyle-questionnaire
Time frame: in-study at week 0, 13; during follow-up at 6, 12 and 24 months
change in vitality as assessed with a vitality questionnaire (Vita-16)
Time frame: in-study at week 0, 13; during follow-up at 6, 12 and 24 months
change in subjective quality of life as assessed with RAND-36 questionnaire
Time frame: in-study at week 0, 13; during follow-up at 6, 12 and 24 months
change in indices for beta cell function
at week 0 and 13 the indices will be calculated from Oral glucose tolerance test data. Blood will be collected at the blood collection centre in Hillegom
Time frame: screening; in-study at week 0 and 13;
change in indices for hepatic insulin resistance
at week 0 and 13 the indices will be calculated from Oral glucose tolerance test data. Blood will be collected at the blood collection centre in Hillegom
Time frame: screening; in-study at week 0 and 13;