NCT02196350

P4 Approach in Diabetes Type 2

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: W.J. Pasman · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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 .

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

Interventions

Type	Name	Description
BEHAVIORAL	Intervention A: Diet	subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice
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.
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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2014-07-22
• Last updated: 2019-10-25

Locations

9 sites across 1 country: Netherlands