INDEPENDENT STATISTICIAN REQUIRED



We are looking for an independent statistician to join the Trial Steering Committee for a study led by Prof Daniel J Cuthbertson. The study is already well into recruitment and this position is to replace the existing independent statistician who has now moved on and is no longer able to fulfil this position.

Trial recruitment is currently ongoing. However, recruitment and study visits were suspended for several months in 2020 due to the COVID-19 pandemic. It is anticipated that the required sample size will be met by the end of July 2021, with last follow-up complete by end of March 2022.

A brief description of the study is presented below.



The aim of the steering committee is to provide overall independent supervision of the trial including safeguarding the interests of the RESILIENT Study participants, assessing the safety and efficacy of the trial. Collectively, the members have the scientific, medical and clinical trial management experience to conduct and evaluate the trial and have joint oversight of the design, conduct and analysis of the study.  The Committee should endeavour to ensure that the trial is conducted at all times to comply with Good Clinical Practice (GCP).

The frequency of scheduled TSC meetings will be at least once a year. The meetings can be attended remotely (I imagine after the pandemic passes too).

If you are interested in supporting the study by becoming the TSC statistician, or would like more information - please contact Dr. Richard Jackson ([log in to unmask]<mailto:[log in to unmask]>) or myself ([log in to unmask]<mailto:[log in to unmask]>), enclosing your research CV and outlining your relevant experience of such committees, if any.
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RESILIENT Study: RandomisEd, controlled, double blind Study to assess mechanistic effects of combination therapy of dapagliflozin with Exenatide QW versus dapagliflozin alone in obese (BMI>30 kg/m2) patients with Type 2 diabetes mellitus.


Brief Description:

This is a phase IV therapeutic use single centre study. Patients with a clinical diagnosis of type 2 diabetes, BMI between 30-50kg/m2 and who meet the entry criteria will be provided with details of the study and consented. Patients will be randomised to one of three treatment arms  and baseline/pre-treatment measures will be taken. Treatment on all three arms will be for 32 weeks, after which follow up/post-treatment measures will be taken.



Primary Objective:

The primary objective of the study is to compare the adjusted mean reduction in total body fat mass from baseline following 32 weeks of treatment with exenatide QW and dapagliflozin versus dapagliflozin alone compared with control (placebo).



Secondary Objectives:

The key secondary objectives are to assess the adjusted mean change from baseline in:

1. Metabolic measures

·         HbA1c (the principal measure of glycaemic control)

·         Fasting glucose

·         Total LDL and HDL cholesterol and triglycerides

·         24 hour urinary glucose excretion

2. Changes in energy balance:

·         Food intake (g and kcal) at ad libitum meals

·         Total energy expenditure: measured by indirect calorimetry using a ventilated hood system and derived using the Weir equation

3. Eating behaviour

·         Visual Analogue Scale (VAS): A 7-component VAS questionnaire used to assess hunger, fullness, prospective food consumption and desire to eat

·         Satiety quotient: measured using VAS ratings and calculated as the difference in hunger pre- and post-meal divided by the caloric intake

·         Psychology of appetite questionnaire scores

4. Changes in body composition

·         Reduction in total body weight (kg)

·         Total fat volume (L) and regional fat volumes (liver fat, pancreatic fat, visceral fat and subcutaneous fat volume) measured by MRI/MRS scanning

·         Changes in lean body mass measured by DEXA

5. Changes in cardiovascular variables

·         Blood pressure

·         Echocardiographic derived left and right ventricular function including systolic and diastolic strain (rate) and twist mechanics

·         Echocardiographic derived epicardial fat

·         Endothelial function: Flow mediated dilatation will be measured in response to an ischaemic stimulus using brachial ultrasound


Thank you and kind regards

Elaine Howarth
Senior Statistician, Liverpool Clinical Trials Centre,
The University of Liverpool, 1st floor Clock C, Waterhouse Building, 3 Brownlow Street, Liverpool. L69 3GL

Email: [log in to unmask]<mailto:[log in to unmask]>



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