ISRCTN34805606
Completed
未知
Delivering a realistic diabetes prevention programme in a UK community: the Norfolk Diabetes Prevention Study (Norfolk DPS)
orfolk and Norwich University Hospital NHS Trust (UK)0 sites1,330 target enrollmentApril 14, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- orfolk and Norwich University Hospital NHS Trust (UK)
- Enrollment
- 1330
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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