Type 2 DiabetesP4P-HillegomNCT02196350
P4 Approach in Diabetes Type 2
A study testing Intervention A: Diet, Intervention B: Exercise and Intervention C: Diet and Exercise in people with Type 2 Diabetes, run by W.J. Pasman at 9 sites in Netherlands.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Intervention A: Diet, Intervention B: Exercise and Intervention C: Diet and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesNetherlands
- Study dates
- Sep 2014to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy as assessed by the
- health and lifestyle questionnaire, (P9607 F02; in Dutch)
- physical examination
- results of the pre-study laboratory tests
- Age 30-80 years
- Stable BMI 25-35 kg/m2
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- Diagnosis diabetes type 2 based upon:
- Fasting glucose >6.9 mmol/l on two different days or one measurement of non-fasting glucose >11.0 mmol/l in combination with symptoms of hyperglycemia
- Duration of diabetes maximally 1 year
- Informed consent signed;
- Willing to comply with the study procedures during the study;
- Appropriate veins for blood sampling/ cannula insertion according to the general practitioner assistant (GPA);
- Voluntary participation
- Physically able to perform training activities
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years.
Who cannot join
- Use of insulin, corticosteroids (systemic), or beta-blockers in past month
- Diabetes occurring after several attacks of pancreatitis known as pancreatic diabetes
- Slow onset type 1 diabetes
- Use of oral diabetes medication in past year
- (Having a history of a) medical condition that might significantly affect the study outcome as judged by the medical investigator and health and life style questionnaire. This includes diabetes type 1, gastrointestinal dysfunction, diseases related to inflammation or allergy, or a psychiatric disorder.
- Hypertension: systolic blood pressure >160 mmHg, diastolic blood pressure >90 mmHg
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- Kidney problems based upon proteinuria and creatinine >150 mmol/l
- Insufficient beta cell function based on Disposition index < 1.5 as determined during the OGTT in study on day 01*
- Physical activity higher than according to the Diabetes guidelines (moderate intensity one hour a day, seven days a week (overweight adults))
- Alcohol consumption > 21 (women) - 28 (men) units/week
- Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
- Recent blood donation (<1 month prior to the start of the study)
- Not willing to give up blood donation during the study
- Personnel of TNO and their partner
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
Huisartsenpraktijk Lommelaars
Hillegom, South Holland, 2181 EK
Huisartspraktijk C.C. Dekker
Hillegom, South Holland, 2181 EN
Huisartspraktijk Tubbergen
Hillegom, South Holland, 2181 EN
Huisartsenpraktijk Sixlaan 9
Hillegom, South Holland, 2182 AA
Huisartsenpraktijk J.G. van Dusseldorp
Hillegom, South Holland, 2182 CA
Huisartsenpraktijk van der Kaaden
Hillegom, South Holland, 2182 GP
Huisartsenpraktijk Elsbroek
Hillegom, South Holland, 2182 LN
Huisartsenpraktijk Mulders
Hillegom, South Holland, 2182 VT
Netherlands Organisation for Applied Scientific Research (TNO)
Zeist, Utrecht, 3704 HE
About this study
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 .
Read the detailed description
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Intervention A: Diet, Intervention B: Exercise, Intervention C: Diet and Exercise
- Keywords
- personalized treatment, prevention, improved diagnosis
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention A: DietBehavioural
Also called very low calorie diet based on Modifast meal replacers.
subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice
Intervention B: ExerciseBehavioural
subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.
Intervention C: Diet and ExerciseBehavioural
Also called very low calorie diet based on Modifast meal replacers.
subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention A: Diet | Experimental | Intervention A: One week of very low calorie diet, 12 weeks of low calorie diet; exercise according to the Dutch Norm for Healthy Behaviour (Nederlandse Norm Gezond Bewegen). Receives: Behavioral: Intervention A: Diet |
| Intervention B: Exercise | Experimental | Intervention B: Combination of strength and endurance training, 3 x per week 60 minutes according to the Exercise Program Diabetes (Beweegprogramma Diabetes).
Healthy isocaloric diet. Receives: Behavioral: Intervention B: Exercise |
| Intervention C: Diet and Exercise | Experimental | Intervention C: one week very low calorie diet, followed by 12 weeks healthy isocaloric diet.
One week exercise according to the Dutch Norm for Healthy Behaviour (Nederlandse Norm Gezond Bewegen) followed by 12 weeks strength and endurance training (3 x per week 60 minutes) according to the Exercise Program Diabetes (Beweegprogramma Diabetes) Receives: Behavioral: Intervention C: Diet and Exercise |
| Control - Historical data | No intervention | Historical data from the GPs Information System from 60 newly diagnosed type 2 diabetes patients in the last five years will be used as control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c levels
Changes in primary outcome measures will be determined by using a mixed model
Measured: 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
Measured: 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.
Measured: 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
Measured: end of study (after 13 weeks)
Secondary outcomes (10)
body weight
measured by the general practitioner assistant
Measured: 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
Measured: 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
Measured: screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months
body fat percentage
measured by general practitioner assistant
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: screening; in-study at week 0 and 13;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.J. Pasman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, W.J. Pasman, TNO
- Investigators
- Wilrike Pasman, PhD, Principal investigator, Netherlands Organisation for Applied Scientific Research (TNO)Peter van Dijken, Dr., Study director, Netherlands Organisation for Applied Scientific Research (TNO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196350
- Sponsor's protocol ID
- P9607
- Acronym
- P4P-Hillegom
- Status last verified
- Oct 2019
- First submitted
- 16 Jul 2014
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the P4 Approach, Preventive, Predictive, Personalized and Participatory in Newly Diagnosed Type 2 Diabetics in Hillegom
- ClinicalTrials.gov ID
- NCT02196350
- Acronym / sponsor ID
- P4P-Hillegom / P9607
- Conditions
- Type 2 Diabetes
- Keywords
- personalized treatment, prevention, improved diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- W.J. PasmanUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention A: Diet | Experimental | Behavioral: Intervention A: DietIntervention A: One week of very low calorie diet, 12 weeks of low calorie diet; exercise according to the Dutch Norm for Healthy Behaviour (Nederlandse Norm Gezond Bewegen). |
| Intervention B: Exercise | Experimental | Behavioral: Intervention B: ExerciseIntervention B: Combination of strength and endurance training, 3 x per week 60 minutes according to the Exercise Program Diabetes (Beweegprogramma Diabetes). Healthy isocaloric diet. |
| Intervention C: Diet and Exercise | Experimental | Behavioral: Intervention C: Diet and ExerciseIntervention C: one week very low calorie diet, followed by 12 weeks healthy isocaloric diet. One week exercise according to the Dutch Norm for Healthy Behaviour (Nederlandse Norm Gezond Bewegen) followed by 12 weeks strength and endurance training (3 x per week 60 minutes) according to the Exercise Program Diabetes (Beweegprogramma Diabetes) |
| Control - Historical data | No intervention | –Historical data from the GPs Information System from 60 newly diagnosed type 2 diabetes patients in the last five years will be used as control. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy as assessed by the
- Age 30-80 years
- Stable BMI 25-35 kg/m2
- Diagnosis diabetes type 2 based upon:
- Fasting glucose >6.9 mmol/l on two different days or one measurement of non-fasting glucose >11.0 mmol/l in combination with symptoms of hyperglycemia
Key exclusion criteria (16 listed)
- Use of insulin, corticosteroids (systemic), or beta-blockers in past month
- Diabetes occurring after several attacks of pancreatitis known as pancreatic diabetes
- Slow onset type 1 diabetes
- Use of oral diabetes medication in past year
- (Having a history of a) medical condition that might significantly affect the study outcome as judged by the medical investigator and health and life style questionnaire. This includes diabetes type 1, gastrointestinal dysfunction, diseases related to inflammation or allergy, or a psychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention A: DietAlso: very low calorie diet based on Modifast meal replacers.subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice | Behavioural | Intervention A: Diet |
| Intervention B: Exercisesubjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice. | Behavioural | Intervention B: Exercise |
| Intervention C: Diet and ExerciseAlso: very low calorie diet based on Modifast meal replacers.subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice. | Behavioural | Intervention C: Diet and Exercise |
Primary outcome
Change in HbA1c levels
Time frame: In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months
Changes in primary outcome measures will be determined by using a mixed model
Change in 2h glucose levels
Time frame: In-study at week 0 (baseline) and 13;
2h glucose will be measured after Oral Glucose Tolerance Test (OGTT). Changes in primary outcome measures will be determined by using a mixed model
Change in fasting blood glucose levels
Time frame: In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months
After 8 hour fasting. Changes in primary outcome measures will be determined by using a mixed model.
percentage of participants that reach normoglycemia
Time frame: end of study (after 13 weeks)
normoglycemia is determined by fasting blood glucose level of less than 6.1 mmol/L
10 secondary outcomes
body weight
Time frame: screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months
blood pressure
Time frame: screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months
waist circumference
Time frame: screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months
body fat percentage
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
Time frame: screening; in-study at week 0 and 13;
health behaviour change
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
Time frame: screening; in-study at week 0 and 13;
change in indices for hepatic insulin resistance
Time frame: screening; in-study at week 0 and 13;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilrike Pasman, PhD principal investigator
Netherlands Organisation for Applied Scientific Research (TNO)
Peter van Dijken, Dr. study director
Netherlands Organisation for Applied Scientific Research (TNO)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention A: Diet, Intervention B: Exercise and Intervention C: Diet and Exercise in people with Type 2 Diabetes, run by W.J. Pasman at 9 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c levels (time frame: In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.