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The DR-EAM Type 2 Diabetes Study

NCT05626842 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2022-11-25

No results posted yet for this study

Summary

The goal of this 12-month interventional study is to analyse the clinical outcome benefits, scalability and cost-effectiveness of a digital Low-Calorie digital Type 2 diabetes mellitus (T2DM) remission program compared to usual National Health System (NHS) care.

Conditions

Interventions

OTHER

Total Diet Replacement (800kcal/day)

The TDR intervention involves a low-calorie, nutritionally complete diet for 12 weeks consuming four meal replacement products exclusively per day, followed by a 4-week food-based reintroduction period; and then weight loss maintenance support monthly for a further 36 weeks. If a patient gains more than 2kg in the maintenance phase, they have the option to follow a TDR for an additional 4 weeks.

Sponsors & Collaborators

  • University of Westminster

    collaborator OTHER

  • Oviva UK Ltd

    lead OTHER

Principal Investigators

  • Lucy Jones

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05626842 on ClinicalTrials.gov