P4 Approach in Diabetes Type 2 (P4P-Hillegom)

October 24, 2019 updated by: W.J. Pasman

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Zeist, Utrecht, Netherlands, 3704 HE
        • Netherlands Organisation for Applied Scientific Research (TNO)
    • Zuid Holland
      • Hillegom, Zuid Holland, Netherlands, 2181 EK
        • Huisartsenpraktijk Lommelaars
      • Hillegom, Zuid Holland, Netherlands, 2181 EN
        • Huisartspraktijk C.C. Dekker
      • Hillegom, Zuid Holland, Netherlands, 2181 EN
        • Huisartspraktijk Tubbergen
      • Hillegom, Zuid Holland, Netherlands, 2182 AA
        • Huisartsenpraktijk Sixlaan 9
      • Hillegom, Zuid Holland, Netherlands, 2182 CA
        • Huisartsenpraktijk J.G. van Dusseldorp
      • Hillegom, Zuid Holland, Netherlands, 2182 GP
        • Huisartsenpraktijk van der Kaaden
      • Hillegom, Zuid Holland, Netherlands, 2182 LN
        • Huisartsenpraktijk Elsbroek
      • Hillegom, Zuid Holland, Netherlands, 2182 VT
        • Huisartsenpraktijk Mulders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy as assessed by the

    • health and lifestyle questionnaire, (P9607 F02; in Dutch)
    • physical examination
    • results of the pre-study laboratory tests
  2. Age 30-80 years
  3. Stable BMI 25-35 kg/m2

  4. 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

  5. Duration of diabetes maximally 1 year
  6. Informed consent signed;
  7. Willing to comply with the study procedures during the study;
  8. Appropriate veins for blood sampling/ cannula insertion according to the general practitioner assistant (GPA);
  9. Voluntary participation
  10. Physically able to perform training activities
  11. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years.

Exclusion Criteria:

  1. Use of insulin, corticosteroids (systemic), or beta-blockers in past month
  2. Diabetes occurring after several attacks of pancreatitis known as pancreatic diabetes
  3. Slow onset type 1 diabetes
  4. Use of oral diabetes medication in past year
  5. (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.
  6. Hypertension: systolic blood pressure >160 mmHg, diastolic blood pressure >90 mmHg
  7. Kidney problems based upon proteinuria and creatinine >150 mmol/l
  8. Insufficient beta cell function based on Disposition index < 1.5 as determined during the OGTT in study on day 01*
  9. Physical activity higher than according to the Diabetes guidelines (moderate intensity one hour a day, seven days a week (overweight adults))
  10. Alcohol consumption > 21 (women) - 28 (men) units/week
  11. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
  12. Recent blood donation (<1 month prior to the start of the study)
  13. Not willing to give up blood donation during the study
  14. Personnel of TNO and their partner
  15. Not having a general practitioner
  16. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention A: Diet
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).
Behavioral: Intervention A: Diet
subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice
Other Names:
  • very low calorie diet based on Modifast meal replacers.
Experimental: Intervention B: Exercise

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.
Behavioral: Intervention B: Exercise
subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.
Experimental: Intervention C: Diet and Exercise

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)
Behavioral: Intervention C: Diet and Exercise
subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.
Other Names:
  • very low calorie diet based on Modifast meal replacers.
No Intervention: Control - Historical data
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months
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
In-study at week 0 (baseline) and 13;
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.
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
Time Frame: end of study (after 13 weeks)
normoglycemia is determined by fasting blood glucose level of less than 6.1 mmol/L
end of study (after 13 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
body weight
Time Frame: screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months
measured by the general practitioner assistant
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
measured by the general practitioner assistant
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
measured by general practitioner assistant
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
measured by general practitioner assistant
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;

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
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
established by comparing baseline values with end of study values for food intake and physical activity as measured by a Lifestyle-questionnaire
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
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
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;

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
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;

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
screening; in-study at week 0 and 13;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
W.J. Pasman

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wilrike Pasman, PhD, Netherlands Organisation for Applied Scientific Research (TNO)
  • Study Director: Peter van Dijken, Dr., Netherlands Organisation for Applied Scientific Research (TNO)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P9607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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