P4 Approach in Diabetes Type 2

Type 2 Diabetes Clinical Trial

— P4P-Hillegom  

Official title:

The Impact of the P4 Approach, Preventive, Predictive, Personalized and Participatory in Newly Diagnosed Type 2 Diabetics in Hillegom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196350
• Other study ID #: P9607
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: July 2019

Study information

• Verified date: October 2019
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Intervention A: Diet
subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice
• 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.
• 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.

Locations

Country	Name	City	State
Netherlands	Huisartsenpraktijk Elsbroek	Hillegom	Zuid Holland
Netherlands	Huisartsenpraktijk J.G. van Dusseldorp	Hillegom	Zuid Holland
Netherlands	Huisartsenpraktijk Lommelaars	Hillegom	Zuid Holland
Netherlands	Huisartsenpraktijk Mulders	Hillegom	Zuid Holland
Netherlands	Huisartsenpraktijk Sixlaan 9	Hillegom	Zuid Holland
Netherlands	Huisartsenpraktijk van der Kaaden	Hillegom	Zuid Holland
Netherlands	Huisartspraktijk C.C. Dekker	Hillegom	Zuid Holland
Netherlands	Huisartspraktijk Tubbergen	Hillegom	Zuid Holland
Netherlands	Netherlands Organisation for Applied Scientific Research (TNO)	Zeist	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
W.J. Pasman

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c levels	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
Primary	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	In-study at week 0 (baseline) and 13;
Primary	Change in fasting blood glucose levels	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
Primary	percentage of participants that reach normoglycemia	normoglycemia is determined by fasting blood glucose level of less than 6.1 mmol/L	end of study (after 13 weeks)
Secondary	body weight	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
Secondary	blood pressure	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
Secondary	waist circumference	measured by general practitioner assistant	screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months
Secondary	body fat percentage	measured by general practitioner assistant	screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months
Secondary	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	screening; in-study at week 0 and 13;
Secondary	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	in-study at week 0, 13; during follow-up at 6, 12 and 24 months
Secondary	change in vitality as assessed with a vitality questionnaire (Vita-16)		in-study at week 0, 13; during follow-up at 6, 12 and 24 months
Secondary	change in subjective quality of life as assessed with RAND-36 questionnaire		in-study at week 0, 13; during follow-up at 6, 12 and 24 months
Secondary	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	screening; in-study at week 0 and 13;
Secondary	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	screening; in-study at week 0 and 13;