Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

October 2, 2015

Primary Completion Date

August 31, 2028

Study Completion Date

August 31, 2028

Conditions
Diabetes
Interventions
DIETARY_SUPPLEMENT

Cambridge Weight Plan

"Group receives a total meal replacement diet from Cambridge Weight Plan containing 810 kcal/day (40% protein, 50% carbohydrate, 10% fat). As 3 or 4 mini-meals daily in flavoured formula food packets made up with water, milk or non-dairy alternative; or as snack bars based on preference. Supplemented with up to three portions of non-starchy vegetables and 2 litres of water, or other non-calorific drinks, per day. Participants to abstain from alcohol for study duration. The diet will be stopped, and a maintenance diet re-introduced once 50% excess body weight has been lost, or by 12 weeks, whichever comes first.~The TDR will be undertaken alongside health behaviour coaching and relapse prevention through weekly, where possible, contact (telephone or face-to-face) with a qualified dietician or equivalent.~Due to the potential risk of hypoglycaemia and symptomatic hypotension; medication at enrolment will need to be adjusted initially and throughout the study."

OTHER

Supervised Exercise Sessions

"The exercise group will attend supervised exercise sessions at the Leicester-Loughborough Diet, Lifestyle and Physical Activity (LLP) BRU or at the Leicester Diabetes Centre. The exercise program will typically consist of a thrice weekly, 60 minute session of moderate intensity aerobic exercise, in line with prevailing guidelines. An initial assessment of cardiorespiratory fitness will be performed, and exercise intensity titrated to aim for a workload of approximately 60% of the patient's VO2 max.~Due to the potential risk of hypoglycaemia and symptomatic hypotension; medication at enrolment will need to be adjusted initially and throughout the study."

Trial Locations (1)

LE3 9QP

RECRUITING

Glenfield Hospital (University Hospitals of Leicester NHS Trust), Leicester

All Listed Sponsors
collaborator

University Hospitals, Leicester

OTHER

collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

lead

University of Leicester

OTHER