Protocol for the specialist supervised individualised multifactorial treatment of new clinically diagnosed type 2 diabetes in general practice (IDA): a prospective controlled multicentre open-label intervention study

Jacob Volmer Stidsen, Jens Steen Nielsen, Jan Erik Henriksen, Søren Gunnar Friborg, Reimar Wernich Thomsen, Thomas Bastholm Olesen, Michael Hecht Olsen, Henning Beck-Nielsen, Jacob Volmer Stidsen, Jens Steen Nielsen, Jan Erik Henriksen, Søren Gunnar Friborg, Reimar Wernich Thomsen, Thomas Bastholm Olesen, Michael Hecht Olsen, Henning Beck-Nielsen

Abstract

Introduction: We present the protocol for a multifactorial intervention study designed to test whether individualised treatment, based on pathophysiological phenotyping and individualised treatment goals, improves type 2 diabetes (T2D) outcomes.

Methods and analysis: We will conduct a prospective controlled multicentre open-label intervention study, drawing on the longitudinal cohort of the Danish Centre for Strategic Research in Type 2 Diabetes (DD2). New clinically diagnosed patients with T2D in the intervention group will be assigned to receive individualised treatment by their general practitioner. Intervention patients will be compared with a matched control cohort of DD2 patients receiving routine clinical care. Among intervention patients, we will first do pathophysiological phenotyping to classify patients into WHO-defined T2D or other specific types of diabetes (monogenic diabetes, secondary diabetes etc). Patients with WHO-defined T2D will then be further subcharacterised by their beta-cell function (BCF) and insulin sensitivity (IS), using the revised homeostatic assessment model, as having either insulinopaenic T2D (high IS and low BCF), classical T2D (low IS and low BCF) or hyperinsulinaemic T2D (low IS and high BCF). For each subtype, a specific treatment algorithm will target the primary pathophysiological defect. Similarly, antihypertensive treatment will be targeted at the specific underlying pathophysiology, characterised by impedance cardiography (relative importance of vascular resistance, intravascular volume and cardiac inotropy). All treatment goals will be based on individual patient assessment of expected positive versus adverse effects. Web-based and face-to-face individualised lifestyle intervention will also be implemented to empower patients to make a sustainable improvement in daily physical activity and to change to a low-carbohydrate diet.

Ethics and dissemination: The study will use well-known pharmacological agents according to their labels; patient safety is therefore considered high. Study results will be published in international peer-reviewed journals.

Trial registration number: NCT02015130; Pre-results.

Keywords: clinical diabetes; individualized treatment; insulin secretion; insulin sensitivity and resistance; pathophysiology; treatment guidelines.

Conflict of interest statement

Competing interests: JEH is a member of the MSD and Boehringer National Advisory Board. HB-N has received personal lecturer’s fees from Novo Nordisk, outside the submitted work. MHO has received a clinical research grant from the Novo Nordisk Foundation. The Department of Clinical Epidemiology, Aarhus University Hospital, receives funding for other studies from companies in the form of research grants to (and administered by) Aarhus University. None of those studies have any relation to the present study.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Study timeline.
Figure 2
Figure 2
Recruitment flowchart at general practitioner (GP) level. DD2, Danish Centre for Strategic Research in Type 2 Diabetes; IDA, Individualised treatment of newly clinical diagnosed T2D in general practice study.
Figure 3
Figure 3
Recruitment (A) and general practitioner (GP) contacts in the intervention group (B). DD2, Danish Centre for Strategic Research in Type 2 Diabetes; IDA, Individualised treatment of newly clinical diagnosed T2D in general practice study; OPC, Outpatient clinic; T2D, type 2 diabetes.

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