Low-Calorie Diet in People With Prediabetes/Metabolic Syndrome

Summary

Significant weight reduction, achieved by low-calorie diet (LCD), will mobilise ectopic fat (visceral and particularly liver fat), improving insulin sensitivity and other metabolic syndrome components, with secondary beneficial effects on cardiac structure and function.

This CALIBRATE study (metabolic, multi-organ and effects of low-calorie diet in younger obese patients with pre-diabetes) will compare the effects of a safe and effective 12-month weight management intervention, initially using a low-calorie, liquid replacement diet for 12 weeks, anticipating at least 10% reduction in body weight. The investigators will examine how much the weight loss improves the metabolic abnormalities that precede type 2 diabetes (T2D), and in reversing the pre-clinical/subtle clinical abnormalities of the liver and heart that precede liver and cardiovascular disease (CVD).

This study will compare the effects of a safe and effective 12-month weight management intervention, initially using a low-calorie, liquid replacement diet for 12 weeks, followed by a weight maintenance phase. The investigators will examine how much the weight loss improves the metabolic and neuropathic abnormalities that precede and accompany type 2 diabetes (T2D), and in reversing the pre-clinical/subtle clinical abnormalities of the liver and heart that precede liver and cardiovascular disease. In an additional optional sub-study, the investigators will additionally assess how the weight loss impacts upon appetite regulation within the brain with functional MRI (fMRI).

Conditions

• Obesity
• NAFLD
• Fatty Liver
• Pre Diabetes
• Metabolic Syndrome

Interventions

OTHER

Standard of care

Participants allocated to the control group will be given standard clinical information regarding healthy eating, physical activity and management of weight, in line with current NHS practise.

DIETARY_SUPPLEMENT

Low-calorie diet

The LCD intervention group, will received a well validated, commercially available, intensive weight management protocol Counterweight-Plus.

Sponsors & Collaborators

• University of Surrey

  collaborator OTHER

• Perspectum

  collaborator INDUSTRY

• University of Liverpool

  lead OTHER

Principal Investigators

• Daniel Cuthbertson · University of Liverpool

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• United Kingdom

Study Locations