The principal goal of this proposal is to use the results of this structured intervention to identify success indicators for implementation of the lifestyle intervention in a real-life setting, in other words: to bring SLIM from research to practice…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the change in glucose tolerance (i.e.
2-hour blood glucose as measured during the OGTT).
Secondary outcome
Secondary outcomes: body weight, body composition, HbA1c, insulin sensitivity,
blood lipid profile, blood pressure, ECG, fitness, physical activity, dietary
habits, smoking and alcohol consumption, medication, quality of life and
medical history, including development of diabetes and cardiovascular
complications.
Background summary
The Study of Lifestyle intervention and Impaired glucose tolerance Maastricht
(SLIM) is a lifestyle intervention study in subjects with impaired glucose
tolerance with a mean follow-up of 5.5 years. The study is unique in the
Netherlands, and shows that a healthy diet and increased physical activity is
effective in improving glucose tolerance, despite moderate weight loss. Also
preliminary results show the cumulative diabetes incidence after 5.5 yr is
significantly lower in the intervention group as compared to the control group,
with a 50% reduction in risk.
Study objective
The principal goal of this proposal is to use the results of this structured
intervention to identify success indicators for implementation of the lifestyle
intervention in a real-life setting, in other words: to bring SLIM from
research to practice.
Study design
For this purpose several sub-questions need to be answered first: - How does
the effect sustain 2 yrs after discontinuation of this long-term intervention?
* What is the profile of subjects that successfully completed the intervention
and maintain this effect after the study? - What barriers and promoting
factors for successful implementation of this structured intervention are
encountered or likely? * What is the cost-effectiveness of the intervention and
various other scenarios? * This will accumulate in the 5th sub-item: the
preparation of an implementation protocol, to prepare the implementation in
Phase II.
Therefore, in the present proposal the first aim is to re-examine all
participants of the SLIM study 2 years after discontinuation of the study.
Study burden and risks
Subjects are asked to visit the hospital twice in a period of 4 weeks time,
during the first visit (of maximal 4 hours) oral glucose tolerance will be
tested after an overnight fast. In total 20ml of venous blood will be sampled.
During the second visit an aerobic fitness test will be performed (max 2
hours). To prevent any risks, especially for the older participants, we will
monitor heart function (ECG) during the test. Furthermore, a medical doctor
will be available on call during the tests.
During the OGTT, a canula will be inserted in a forearm vein. Venapunctures can
occasionaly cause a local bruise. Some participants report pain during
venapuncture.
Universiteitssingel 50
6229 ER Maastricht
NL
Universiteitssingel 50
6229 ER Maastricht
NL
Listed location countries
Age
Inclusion criteria
Previous participants of the SLIM.
Exclusion criteria
Abnormal ECG during first visit and history of heart attack are exclusion criteria for the fitness test.
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 |
|---|---|
| CCMO | NL23892.068.08 |
| Other | Protocol wordt momenteel geregistreerd bij clinicaltrials.gov. Nummer nog niet bekend. |