The main objective is to assess the impact of the P4 approach on established markers of glucose metabolism. Secondary objectives are changes in physical characteristics, questionnaires and the indices for beta cell function, hepatic insulin…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A diversity of parameters related to glucose metabolism will be measured before
and after the three month intervention period. Primary study parameters will be
HbA1c, fasting plasma glucose (FPG), 2h glucose after oral glucose tolerance
test (OGTT).
Secondary outcome
In addition, diabetes medication, quality of life (QoL) and lifestyle
questionnaires, lipid profile, blood pressure, body weight (BW), waist
circumference (WC), body mass index (BMI), body fat%, and indices for beta cell
function, hepatic insulin resistance and muscle insulin resistance during OGTT
will be determined as secondary study parameters.
Finally, the number of participants that reach normoglycemia (fasting blood
glucose level of less than 6.1 mmol/L ) will be determined as derivative of the
fasting blood glucose for each subject at the end of the study (wk 13) as well
as after two years of follow-up.
Background summary
Rationale: Diabetes Mellitus type 2 (T2D) is an enormous and increasing
societal and economic burden. Insulin resistance in muscle and liver tissue and
beta-cell failure represent the core pathophysiological defects in T2D.
Prediabetics develop these symptoms. The primary symptom is high plasma glucose
and medical treatment focuses on lowering glucose by reducing glucose synthesis
or increasing insulin excretion. Remarkably, the real problem (specific organ
dysfunction) is hardly addressed except by lifestyle changes restoring the
energy balance (*eat less and exercise more*). Increasing evidence of distinct
subgroups within the T2D population and prediabetes population exists, which
may require tailored treatment approaches instead of a *one-size fits all*
treatment. The P4 approach provides an innovative method to predict (P1) which
organ failure must be treated, to prevent (P2) further deterioration and
stimulate improvement, to personalize (P3) diagnosis and tailor treatment, and
to enhance participation (P4) of patients. The complete program resulting from
the integration of these four terms is called the *P4 approach*.
Study objective
The main objective is to assess the impact of the P4 approach on established
markers of glucose metabolism. Secondary objectives are changes in physical
characteristics, questionnaires and the indices for beta cell function, hepatic
insulin resistance and muscle insulin resistance as calculated from the OGTT
response in the different P4 intervention groups.
Study design
Proof-of -principle exploratory study assessing the impact of the P4 approach
in prediabetics and diabetes type 2 patients. The study is an open,
non-randomized study.
As control, historical data from the GPs Information System from newly
diagnosed diabetes patients and prediabetics in the last five years will be
used.
Intervention
Prediabetics and newly diagnosed type 2 diabetics are presented the choice of
participating in the P4 program. After investigation of the status of the
different organs involved in diabetes, subjects are divided into three
subgroups. Each subgroup receives a personalized lifestyle advice. The
lifestyle advice may comprise different interventions, varying in severity of
the diet ((very) low calorie diet) and type of physical activity (strength
training, endurance training) or a combination of both.
Study burden and risks
We do not foresee any health risk. The subjects in the intervention group
receive personalized treatment, provided by health care insurances as well. The
intervention will be under supervision of their own general practitioner.
The Modifast diet may result in formation of gall stones. The short period (one
week) and the regular control by professionals will result in frequent
investigation of adverse events. Patients with low beta-cell function will not
undergo one week VLCD, but only LCD (less strict).
During the intervention period of three months subjects visit the
physiotherapist for their exercise activities (three times per week) and the
dietician every 2-4 weeks. The possible occurrence of injuries will be
prevented bu the guidance of physiotherapists.
At the beginning of the intervention and after three months an OGTT test will
be performed. Physical performance and different anthropometric measures will
be determined.
After the intervention period the subjects will return to usual care via the
general practitioner. Dietary support will be available via three additional
consults with the dietician. In addition, subjects will be given the choice of
participating in an exercise program consisting of weekly visits with an
exercise coach of the Hillegom community during three months.
After 6, 12 and 24 months follow-up measurements will consist of the above
mentioned parameters for glucose metabolism with the exception of the OGTT, in
addition to lifestyle questionnaires.
The beneficial effects of the study may be deteriorate when the intervention is
stopped and subjects do not comply to the treatment anymore.
The (pre)diabetic study population is chosen because of the increase in
prevalence of diabetes type 2. The type of intervention, personalized lifestyle
intervention, may be most appropriate in this group of patients.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
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 or preidabetes (fasting glucose between 6.1-6.9 mmol/L)
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
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. Physical activity higher than according to the Diabetes guidelines(1 hour a day)
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. Personnel of TNO and their partner
14. Not having a general practitioner
15. 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02196350 |
| CCMO | NL48742.028.14 |