The Personalized Dietary Advice Services: Effects of use by the dietician on health status of diabetes type 2 patients
- Conditions
- Diabetes type 2Glucose disturbed1001842410012653
- Registration Number
- NL-OMON41796
- Lead Sponsor
- TNO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Age 30-80 years;
2. Stable BMI 25-35 kg/m2
3. Diabetes type 2 as diagnosed by the GP, 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
4. Healthy as assessed by the health and lifestyle questionnaire (P9607 F02; in Dutch);
5. Voluntary participation;
6. Informed consent signed;
7. Willing to comply with the study procedures;
8. Willingness to share pseudonymized data on food intake with external party MijnEetmeter (food intake app provider)
9. Willingness to share pseudonymized data on physical activity with external party Medisana (provider of activity tracker)
10. Willingness to share pseudonymized data on food intake, blood glucose, blood cholesterol, blood pressure, physical activity and body weight with the Nutrition Research Cohort (NRC) database
11. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for 15 years.
12. Have a desktop or laptop with internet access at home.
1. Use of concomitant medication including medication known for its effects the main study parameters, except for medication for diabetes type 2, cholesterol or blood pressure;
2. Use of insulin or Sulfonyl Urea derivatives;
3. Slow onset type 1 diabetes;
4. Diabetes occurring after several attacks of pancreatitis known as pancreatic diabetes;
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. Following a medically prescribed diet, other than dietary advice for diabetes type 2;
7. Use of nutritional supplements that could influence the study outcome, including vitamin supplements, fish oil and/or omega fatty acids;
8. Physical, mental or practical limitations in using computers;
9. Alcohol consumption > 21 (women) - 28 (men) units/week;
10. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening;
11. Recent blood donation (< 1 month prior to the start of the study);
12. Not willing to give up blood donation during the study;
13. Not having a general practitioner;
14. Personnel of TNO in Zeist and Soesterberg and their partners.
15. Not willing to accept information-transfer concerning study participation, or health-related information, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from the participant*s general practitioner.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study parameters will be fasting plasma glucose (FPG), HbA1c and<br /><br>fasting insulin. These variables will be measured at the beginning of the<br /><br>run-in week (week -2) and at the end of the intervention (week 13) and will be<br /><br>compared with the control group. By comparing the effects of the intervention<br /><br>to data from a control group receiving regular care, the added value of the<br /><br>Personalized Dietary Advice Services for participants can be estimated. </p><br>
- Secondary Outcome Measures
Name Time Method