Type 2 Diabetes
Conditions
Keywords
personalized treatment, prevention, improved diagnosis
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 .
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.
Interventions
BEHAVIORALIntervention A: Diet
subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice
BEHAVIORALIntervention 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.
BEHAVIORALIntervention 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
W.J. Pasman
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c levels | 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 |
| Change in 2h glucose levels | 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 |
| Change in fasting blood glucose levels | 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. |
| percentage of participants that reach normoglycemia | end of study (after 13 weeks) | normoglycemia is determined by fasting blood glucose level of less than 6.1 mmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| waist circumference | screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months | measured by general practitioner assistant |
| body fat percentage | screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months | measured by general practitioner assistant |
| change indices for muscle insulin resistance | 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 |
| 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 | — |
| change in indices for beta cell function | 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 |
| change in indices for hepatic insulin resistance | 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 |
| health behaviour change | 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 |
| 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 | — |
| body weight | 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 |
| blood pressure | 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 |
Countries
Netherlands
Outcome results
None listed