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Trial record 2 of 4 for:    Pasman | diabetes | Netherlands
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P4 Approach in Diabetes Type 2 (P4P-Hillegom)

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ClinicalTrials.gov Identifier: NCT02196350
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
W.J. Pasman, TNO

Study Description
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Brief 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 .


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Intervention A: Diet Behavioral: Intervention B: Exercise Behavioral: Intervention C: Diet and Exercise Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Impact of the P4 Approach, Preventive, Predictive, Personalized and Participatory in Newly Diagnosed Type 2 Diabetics in Hillegom
Actual Study Start Date : September 2014
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


  6. 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

  7. 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 ]
  8. 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 ]
  9. 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


  10. 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



Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196350


Locations
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Netherlands
Netherlands Organisation for Applied Scientific Research (TNO)
Zeist, Utrecht, Netherlands, 3704 HE
Huisartsenpraktijk Lommelaars
Hillegom, Zuid Holland, Netherlands, 2181 EK
Huisartspraktijk C.C. Dekker
Hillegom, Zuid Holland, Netherlands, 2181 EN
Huisartspraktijk Tubbergen
Hillegom, Zuid Holland, Netherlands, 2181 EN
Huisartsenpraktijk Sixlaan 9
Hillegom, Zuid Holland, Netherlands, 2182 AA
Huisartsenpraktijk J.G. van Dusseldorp
Hillegom, Zuid Holland, Netherlands, 2182 CA
Huisartsenpraktijk van der Kaaden
Hillegom, Zuid Holland, Netherlands, 2182 GP
Huisartsenpraktijk Elsbroek
Hillegom, Zuid Holland, Netherlands, 2182 LN
Huisartsenpraktijk Mulders
Hillegom, Zuid Holland, Netherlands, 2182 VT
Sponsors and Collaborators
W.J. Pasman
Investigators
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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)
More Information
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Responsible Party: W.J. Pasman, PhD, TNO
ClinicalTrials.gov Identifier: NCT02196350    
Other Study ID Numbers: P9607
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Keywords provided by W.J. Pasman, TNO:
personalized treatment
prevention
improved diagnosis