orfolk Diabetes Prevention Study

Not Applicable

Completed

• Conditions: Type 2 diabetes, non-diabetic hyperglycaemia, impaired glucose regulation (IGR); Nutritional, Metabolic, Endocrine; Type 2 diabetes mellitus

• Registration Number: ISRCTN34805606
• Lead Sponsor: orfolk and Norwich University Hospital NHS Trust (UK)

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28056894 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29674706 results (added 17/04/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31245004 results (added 03/02/2020) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31420897 results (added 03/02/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33136119/ results (added 03/11/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34407811/ (added 19/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-14
• Study Completion: 2018-04-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1330

Inclusion Criteria

1. Fasting plasma glucose 5.6 - 6.0 mmol/l AND HbA1c 42 - 47 inclusive on two occasions, OR fasting plasma glucose 6.1 - 6.9 inclusive on two occasions, both categories for the diabetes prevention project
2. Fasting plasma glucose > or = to 7.0 mmol/l on two occasions, OR HbA1c > or = to 48 mmol/mol on two occasions for the screen-detected Type 2 diabetes project
3. These criteria are gender independent, but main search criteria for subjects through primary care databases is 40 - 80 years old

Exclusion Criteria

1. Not able to provide GP details i.e. not registered with a GP or unwilling for their GP to be contacted
2. Unable to give informed consent due to lack of capacity through severe mental health, learning difficulties or significant cognitive impairment
3. Self-reported conditions which could adversely affect the trial results or patient clinical well being such as:
3.1. Terminal illness
3.2. Antipsychotic medication, which may affect glucose tolerance
3.3. High dose oral steroids (> 4 weeks or > 7.5 mg)
3.4. Active treatment for malignancy
3.5. Stage IV renal impairment or ongoing renal dialysis
3.6. Pregnant or lactating
3.7. Stage IV NYHA cardiac failure
4. Taking part in any research study which involves a dietary or lifestyle change intervention (exceptions are participants in observational research studies and EPIC*). Participation in other research studies will be assessed on an individual basis
5. Inability to attend or comply with the interventions or follow-up scheduling
6. Living with or related to someone in the programme team
7. GP advice on health grounds that the participant should not take part or be contacted

Study & Design

• Study Type: Interventional
• Study Design: Not specified