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

Completed

Conditions: diabetes
10018424

Registration Number: NL-OMON41479

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2467

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 < 24 months, management by lifestyle with or without metformin therapy, HbA1c < 7.6% within previous 3 months, white European, age > 35 and < 75y and eGFR > 50ml/min.;Participants also have to speak, read and write Dutch to participate.

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 < 20 or > 50 kg/m2.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the rate of glycaemic deterioration in people with<br /><br>type 2 diabetes and in people at high risk for type 2 diabetes, identifying<br /><br>fast and slow deteriorators.</p><br>

Secondary Outcome Measures