To study the potential of the daily use of a mini-trampoline or metformin added to the NHG -guided lifestyle to cure early type 2 diabetes in overweight and obese patients. PICO research question. What is the effect of the mini-trampoline or…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes of the BMI study:
Remission of diabetes after 1, 2, 3 and / or 4 years.
Remission of diabetes is defined as an HbA1c level < 48 mmol/mol (6.5%) and an
FPG <= 6.9 mmol/l in the absence of any diabetes medication (but metformin) or
bariatric surgery.
Reduction of HbA1c.
Secondary outcome
Secondary outcomes of the BMI study are blood pressure, heart rate, need for
additional pharmacotherapy, insulin resistance (with fasting insulin,
C-peptide, FPG) , body weight, body mass index, waist-hip ratio, body
composition, muscle strenght development of co-morbidity, development of
infections, metabolic and biomarkers in blood and urine (predefined list, like
Advanced Glycation Endproducts, AGE*s) , treatment satisfaction, quality of
life (EQ5D-5L) and physical activity as well as cost utility & effectiveness
analyses by a HTA expert (HTA = health technology assessment).
Background summary
Type 2 diabetes has a huge impact on morbidity, mortality and costs for the
community worldwide. Early treatment may help to reverse type 2 diabetes. Smart
approaches to improve lifestyle, body composition and insulin sensitivity may
be successful, especially if started early. Therefore, we designed the Bouncing
Metformin Intervention (BMI) Study.
Study objective
To study the potential of the daily use of a mini-trampoline or metformin added
to the NHG -guided lifestyle to cure early type 2 diabetes in overweight and
obese patients.
PICO research question. What is the effect of the mini-trampoline or metformin,
added to routine care compared to routine care only, on the presence and
development of early type 2 diabetes in overweight and obese patients?
Study design
This study is an open label RCT to study the effects of the daily use of a
mini-trampoline (Bellicon R - also suitable for fragile persons) or metformin
versus control group on predefined outcomes. After randomization (stratified
for age and BMI), patients will be 1:1:1 allocated to group C (Controls), group
B (Bouncing) or group M (Metformin), and subsequently be treated during an
intervention period of 2 years, followed by an observation period of 2 years.
All patients (N=300, n=100 per group) will receive lifestyle consultation
according to the NHG standard - embedded in regular practice.
Intervention
Routine Care. All patients are treated according protocol and good clinical
practice with counselling for a healthy lifestyle. All participants in all
groups will note in an diary, once weekly, the duration, frequency, type and
intensity of their physical activities/ exercises. Additionally, every year
questionnaires will be used.
Intervention with the mini-trampoline. Participants in group B are trained to
stimulate the adherence to the daily use of the mini-trampoline (15 minutes per
day - possible more). This intervention will be specifically monitored by
sensors.
Intervention with metformin for insulin sensitization. Participants in group M
receive metformin, 850 mg up to 3 times daily, if tolerated, unless
contraindicated. The daily dose of metformin is minimized at 850 mg and
maximized at 2550mg. In the BMI study, metformin is primarily used as a
prevention drug.
Study burden and risks
The burden and risks of this study are minimal. In all study groups, we intend
to improve the quality of life to reduce overweight / obesity and to invert
early type 2 diabetes.
Mild burdens can be expressed as:
1. protocol visits (14 )
2. venous punctures (8 x 40 ml in 4 years)
3. mild side effects of metformin use
4. muscle transient pain due to exercise
Dr. G.H. Amshoffweg 1
Hoogeveen 7909 AA
NL
Dr. G.H. Amshoffweg 1
Hoogeveen 7909 AA
NL
Listed location countries
Age
Inclusion criteria
Early type 2 diabetes diagnosed within 4 years before inclusion:
• FPG > 6.9 mmol/l and/or
• PPG > 11.0 mmol/l and/or
• HbA1c 48 - 64 mmol/mol
FPG = fasting plasma glucose; PPG = postprandial plasma glucose
Willing and able to use the Bellicon on a daily basis
BMI 25 - 40 kg/m2
Age 30 - 80 years
Exclusion criteria
HbA1c >64 mmol/mol
Use of antidiabetic agents during the last 2 months before inclusion
Compelling need for antidiabetic agent (e.g. SGLT2 inhibition)
Contra-indication or intolerance for metformin use
Bariatric surgery
Type 1 diabetes
Expected bad compliance
Serious psychiatric illness
Malignancy, except nonmelanoma skin cancer
Pregnancy or willing to become pregnant within 2 years
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2021-005568-23-NL |
| CCMO | NL79388.042.21 |