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pREdictive Modelling IN Diabetes

Modelling fluctuations in blood glucose levels based on food intake and physical activity in patients with Diabetes Mellitus Type 2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27187
Enrollment
5
Registered
2019-03-20
Start date
2019-03-18
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Diabetes Mellitus Type 2

Interventions

During a two-week period, participants will be asked to follow a protocol during a controlled period 4 hours pre-prandial until 4 hours post-prandial of dinner in which standardized low fat and carboh

Sponsors

Dr. G.D. Laverman, Internal medicine/nephrology, ZGT Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Is diagnosed with diabetes mellitus type 2 • Is aged between 25 and 70 years • Receives diabetic treatment based on long term medication • Has a BMI between 25 and 40 kg/m2 • Is able to do 30 min of walking at a steady pace

Exclusion criteria

Exclusion criteria: • Is receiver of short term/acute diabetic medication. • Has any gastrointestinal disorder that is expected to have clinical relevant effect on the uptake of nutrients from the gut. • Has any medical condition that prevents performing the required procedures. • Has uncontrolled thyroid diseases. • Is allergic to any substance present in any of the standardized meals.

Design outcomes

Primary

MeasureTime frame
As the outcome of the model will be the change in blood glucose levels, to assess the models’ performance, subcutaneous blood glucose will be measured.

Secondary

MeasureTime frame
The developed model will be dependent on several parameters; these will be measured to have them available as input variable: • Physical activity • Food intake

Contacts

Public ContactDr. G.D. Laverman

ZGT Almelo, Zilvermeeuw 1, 7600SZ, Almelo, The Netherlands

G.Laverman@zgt.nl088-7083079

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)