Effect of day-to-day variation, glucose-lowering medication and long term follow-up on type 2 diabetes phenotypes

Abstract

Background: DD2 is developing a novel approach for phenotyping patients with type 2 diabetes (T2D) using the homeostasis model of assessment version 2 (HOMA2). Diabetes phenotyping is proposed as a diagnostic tool in individualizing type 2 diabetes treatment. However, the effect of day-to-day variation, glucose-lowering medication and long term follow-up on the phenotyping has not been evaluated.

Aim: The aim of the study is to measure the effect of day-to-day variation, glucose-lowering medication and long term follow-up on the diabetes phenotyping using HOMA2.

Methods: 193 patients will be asked to participate. Preferentially, patients enrolled in DD2 will be recruited, within 1 month of the DD2 blood sample. In addition non-DD2 patients will be invited to participate if necessary. All patients will be invited to 3 fasting blood samples for analysis of fasting blood glucose, C-peptide and GAD-antibodies. They will be asked to discontinue glucose-lowering medication 7 days between the two last blood samples. Phenotyping will be performed according to the previous published algorithm on all 3 distinct samples and compared. After 4 and 8 years all patients will be offered 2 fasting blood samples with the latter being performed after 7 days of discontinuation of glucose-lowering medication.

Perspectives: Phenotyping in the clinical setting has the potential to improve diabetes treatment via individualized treatment. The knowledge of day-to-day variation and effect of glucose-lowering medication will be an important step towards the clinical application of the phenotyping and individualized treatment.

Formål

1. To estimate the day-to-day variation of the classification of type 2 diabetes phenotypes
2. To estimate the effect of glucose-lowering medication on the classification of type 2 diabetes phenotypes
3. To estimate how the classification changes after 4 and 8 years.
4. To evaluate the potential effect of sample handling and shipment in DD2 on the phenotypes

Studiepopulation

Inclusion criteria:

1) Diagnose of clinical type 2 diabetes within 2 years

2) Currently taking glucose-lowering mediation (predominantly metformin)

In order to maximize the number of patients with less prevalent phenotypes (insulinopenic and hyperinsulinemic) patients with BMI<28 and BMI>33 is preferred, with an estimated 50% having BMI<28.