Use of minitrampoline or metformin added to lifestyle to cure early type 2 diabetes

Bouncing Metformin Intervention (BMI) Study: a long term randomized controlled trial to cure early type 2 diabetes. - BMI Study

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005568-23-NL

Enrollment

300

Registered

2021-12-16

Start date

2022-04-05

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early type 2 diabetes

Interventions

Trade Name: Metformin HCL TEVA 850 mg Product Name: Metformin HCL TEVA 850 mg Product Code: RVG 26048 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Early type 2 diabetes diagnosed within 1 year before inclusion: • FPG > 6.9 mmol/l and/or • PPG > 11.0 mmol/l and/or • HbA1c 48 – 58 mmol/mol FPG = fasting plasma glucose; PPG = postprandial plasma glucose Willing and able to use the BelliconR (mini-trampoline) on a daily basis BMI 25-40 kg/m2 Age 30-70 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: HbA1c > 58 mmol /mol Use of antidiabetic agents during the last 2 months before inclusion 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 outcomes

Primary

Measure	Time frame
Main Objective: To investigate ehether metformin or the use of a minitrampoline on top of standard of care (compared to standard of care alone) may help to cure early type 2 diabetes. Please see protocol for details;Secondary Objective: Metabloic and vascular outcomes. Please see protocol for details.;Primary end point(s): Please see E2.1 above and protocol for details;Timepoint(s) of evaluation of this end point: 1,2,3 and / or 4 years after inclusion	—

Measure

Time frame

Main Objective: To investigate ehether metformin or the use of a minitrampoline on top of standard of care (compared to standard of care alone) may help to cure early type 2 diabetes. Please see protocol for details;Secondary Objective: Metabloic and vascular outcomes. Please see protocol for details.;Primary end point(s): Please see E2.1 above and protocol for details;Timepoint(s) of evaluation of this end point: 1,2,3 and / or 4 years after inclusion

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Secondary

Measure	Time frame
Secondary end point(s): Please see E2.2 above and protocol for details;Timepoint(s) of evaluation of this end point: after 2 and 4 years, with complete dataset	—

Countries

Netherlands

Contacts

Public ContactBMI Study BDRC

Bethesda Diabetes research Center

bdrc@treant.nl+31(0)881296859

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026