P4 Approach in Diabetes Type 2 (P4P-Hillegom)

W.J. Pasman

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Intervention B: Exercise; Behavioral: Intervention C: Diet and Exercise; Behavioral: Intervention A: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02196350

P9607

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Intervention A: Diet

Experimental group

Description:

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).

Treatment:

Behavioral: Intervention A: Diet

Intervention B: Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention B: Exercise

Intervention C: Diet and Exercise

Experimental group

Description:

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)

Treatment:

Behavioral: Intervention C: Diet and Exercise

Control - Historical data

No Intervention group

Description:

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.