P4 Approach in Diabetes Type 2
NCT02196350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2019-10-25
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 .
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
W.J. Pasman
lead OTHER
Principal Investigators
-
Wilrike Pasman, PhD · Netherlands Organisation for Applied Scientific Research (TNO)
-
Peter van Dijken, Dr. · Netherlands Organisation for Applied Scientific Research (TNO)
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2019-07-31
- Completion
- 2019-07-31
Countries
- Netherlands
Study Locations
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