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Follow-up New Hoorn Study - Diabetes research on patient stratification: glycaemic deterioration.

Follow-up New Hoorn Study - Diabetes research on patient stratification: glycaemic deterioration. - Follow-up NHS - DIRECT: glycaemic deterioration.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41479
Enrollment
2467
Registered
2012-12-14
Start date
2013-03-15
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

diabetes

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All surviving subjects who participated in 2006 - 2008 in the New Hoorn Study, since 2003/2004 in the RISC study or in 2005 - 2006 in the Hoorn meal study will be invited for this study.;Additional recruitment of subjects diagnosed with type 2 diabetes (to reach targets for DIRECT Study 2): patients diagnosed with type 2 diabetes for > 3 months and 35 and 50ml/min.;Participants also have to speak, read and write Dutch to participate.

Exclusion criteria

Exclusion criteria: Overall: Inability to give written informed consent (for instance due to dementia).;Study 1 and 2: pregnancy, lactation or a female planning to conceive within the study period, any significant medical reason for exclusion as determined by the investigator, unable to give written informed consent, unable to speak, read and/or write Dutch.;Study 1: Diabetes of any type, treatment with insulin sensitizing, glucose lowering, or other anti-diabetic drugs, HbA1c > 6,5%.;Study 2: type 1 diabetes, a previous HbA1c > 9.0%, prior treatment with insulin or an OHA other than metformin, BMI 50 kg/m2.

Design outcomes

Primary

MeasureTime frame
The main study parameter is the rate of glycaemic deterioration in people with type 2 diabetes and in people at high risk for type 2 diabetes, identifying fast and slow deteriorators.

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)