The Transform Type 2 Diabetes Study

NCT05648903 | Unknown DMC

• 2 other identifiers: Transform studyIRAS ID: 295915
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this mixed-methods, 12-month interventional study is to understand the effectiveness and acceptability of dietary interventions in type 2 diabetes mellitus (T2DM) in an ethnically diverse population. Three dietary interventions will be offered (total diet replacement, intermittent fasting and a low-carbohydrate diet) and two modes of remote care delivery will be used (group and one-to-one).

Conditions

Type2diabetes

Keywords

Type 2 Diabetes; dietary intervention; digital; diverse population; low carbohydrate; low energy; intermittent fasting

Outcome Measures

Primary Outcomes (1)

• Intervention primary outcome- Change in Hba1c (mmol/l)

  Evaluating improvement in Hba1c (mmol/l) upon dietary intervention

  at 6, 12 & 24 months

Secondary Outcomes (6)

• Intervention secondary outcome- weight

  at 6, 12 & 24 months

• Intervention secondary outcomes- lipids

  12 & 24 months

• Intervention secondary outcomes- blood pressure

  12 & 24 months

• Intervention secondary outcomes- NHS resource use including medication cost

  12 & 24 months

• Intervention secondary outcomes- change in quality of life

  baseline & 12 months

Other Outcomes (2)

• Other study outcomes- Patient questionnaires on acceptability, motivations and preferences

  4 & 12 months

• Other study outcomes- engagement with the programme

  12 months

Study Arms (2)

One-to-one

EXPERIMENTAL

All participants are offered a choice of three dietary approaches.

Other: Total diet replacement; Other: Low-carbohydrate diet; Other: Intermittent fasting 5:2

Group

EXPERIMENTAL

All participants are offered a choice of three dietary approaches.

Other: Total diet replacement; Other: Low-carbohydrate diet; Other: Intermittent fasting 5:2

Interventions

Total diet replacement OTHER

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 to 12 months. The TDR products will be provided to participants free of charge. If a patient gains more than 2kg in the maintenance phase, they have the option to follow a TDR for an additional 4 weeks but participants would have to self-fund these products.

Also known as: TDR

Group; One-to-one

Low-carbohydrate diet OTHER

Participants who choose this intervention will be supported to undertake a low-carbohydrate diet. During the first 12 weeks of the programme patients will be supported to consume below 100g carbohydrate per day, whilst being encouraged to increase protein, choose predominantly unsaturated fats alongside a high intake of non-starchy vegetables and low-carbohydrate fruits. After 12 weeks patients will be able to increase their carbohydrate intake up to 130g per day. If a patient gains more than 2kg in the maintenance phase, they have the option to follow a 100g carbohydrate for an additional 4 weeks.

Group; One-to-one

Intermittent fasting 5:2 OTHER

Participants will have the option to follow a 5:2 dietary approach whereby calories are significantly reduced on two days of the week to 500 calories per day for women and 600 calories per day for men. The placement of the "fasting" days can vary each week, but there must be two "fasting" days in each seven-day period. After 12 weeks, patients will have the option of continuing with the 5:2 approach for further weight loss or adopting a 6:1 approach whereby patients would only fast on 1 day in each seven-day cycle for weight maintenance. If a patient gains more than 2kg in the maintenance phase, they have the option to follow a 5:2 approach for an additional 4 weeks.

Also known as: 5:2

Group; One-to-one

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Registered with one of the Nexus Group GP Practices
• Willing to give consent for participation including collection of clinical outcomes
• Diagnosis of type 2 diabetes
• Minimum age of 18 years
• Maximum age of 70 years
• Minimum BMI of 27kg/m² (adjusted to 25kg/m² in people of South Asian or Chinese origin)
• Upper weight limit of 180kg (due to upper weight limit of BodyTrace scales)
• HbA1c eligibility:
• If on diabetes medication, HbA1c ≥ 43 mmol/mol
• If on diet alone, HbA1c ≥ 48 mmol/mol
• HbA1c \<108mml/mol
• Ability to speak, read and receive care in English
• Access to internet and email address

You may not qualify if:

• Currently taking insulin
• Pregnant or planning to be pregnant in the next 6 months
• Current breastfeeding
• Significant physical comorbidities:
• Active cancer, receiving treatment
• Myocardial infarction or stroke in last 6 months
• Severe heart failure defined as equivalent to the New York heart Association grade 3 or 4 (NYHA)
• eGFR \<30 mls/min/1.73m2
• Active liver disease (except non-alcoholic fatty liver disease (NAFLD),Severe angina, cardiac arrhythmia including atrial fibrillation or prolonged QT syndrome
• Active substance use disorder
• Active eating disorder
• Porphyria
• On current weight management programme / had or awaiting bariatric surgery (unless willing to come off waiting list)
• Health professional assessment that the person is unable to understand or meet the demands of the programme and/or monitoring requirements
• Taking monoamine-oxidase inhibitor medication

Sponsors & Collaborators

• Oviva UK Ltd: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

Oviva UK ltd

London, SE1 9RS, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Intermittent Fasting

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lucy Jones

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two modes of remote care delivery are used (one-to one and group).

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 13, 2022
• Study Start: January 7, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)