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Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND) in primary care: A protocol for a cluster randomised trial.

Contemporary clinical trials
June 1, 2023
Jadine Scragg et al. (14 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether the DIAMOND programme, a low-energy, low-carbohydrate diet, could induce remission of type 2 diabetes and reduce cardiovascular disease risk compared to usual care.

Results Summary

The study will measure diabetes remission (HbA1c < 48 mmol/mol and off glucose-lowering medication for 6 months) and assess long-term outcomes like microvascular and macrovascular disease incidence. Results are pending as the study is ongoing.

Population

508 people with type 2 diabetes diagnosed within 6 years, demographically representative of the UK population.

Effective Dosage

Not specified

Duration

6 months (with follow-up at 1 year)

Interactions

None mentioned

Extracted Claims (4)
InterventionDirectionEndpointPopulationDosageImpactClaim #
low-energy diet achieved through total dietary replacement products
decrease
type 2 diabetes (T2D) remission
-
-
can be achieved
#1
low-carbohydrate diets
decrease
remission of T2D
-
-
can achieve
#2
DIAMOND programme
decrease
inducing remission of T2D
people with T2D
-
compares the effectiveness
#3
DIAMOND programme
decrease
reducing risk of cardiovascular disease
people with T2D
-
compares the effectiveness
#4
Abstract

INTRODUCTION: There is strong evidence that type 2 diabetes (T2D) remission can be achieved by adopting a low-energy diet achieved through total dietary replacement products. There is promising evidence that low-carbohydrate diets can achieve remission of T2D. The Dietary Approaches to the Management of type 2 Diabetes (DIAMOND) programme combines both approaches in a behaviourally informed low-energy, low-carbohydrate diet for people with T2D, delivered by nurses in primary care. This trial compares the effectiveness of the DIAMOND programme to usual care in inducing remission of T2D and in reducing risk of cardiovascular disease. METHODS AND ANALYSIS: We aim to recruit 508 people in 56 practices with T2D diagnosed within 6 years, who are demographically representative of the UK population. We will allocate general practices, based on ethnicity and socioeconomic status, to provide usual care for diabetes or offer the DIAMOND programme. Participants in practices offering DIAMOND will see the nurse seven times over 6 months. At baseline, 6 months, and 1 year we will measure weight, blood pressure, HbA1c, lipid profile and risk of fatty liver disease. The primary outcome is diabetes remission at 1 year, defined as HbA1c < 48 mmol/mol and off glucose-lowering medication for at least 6 months. Thereafter, we will assess whether people resume treatment for diabetes and the incidence of microvascular and macrovascular disease through the National Diabetes Audit. Data will be analysed using mixed-effects generalised linear models. This study has been approved by the National Health Service Health Research Authority Research Ethics Committee (Ref: 22/EM/0074). TRIAL REGISTRATION NUMBER: ISRCTN46961767.

Medical Subject Headings (MeSH)
HumansDiabetes Mellitus, Type 2Diet, Carbohydrate-RestrictedGlycated HemoglobinPrimary Health CareState MedicineRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations1
Citations/Year0.5
Relative Citation Ratio0.25
NIH Percentile13%
Research Impact Scores
APT Score0.50
Weight Score2.53
Normalized Score0.67
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