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Clinical Trials/ISRCTN34805606
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)

Registry
who.int
Start Date
April 14, 2016
End Date
April 1, 2018
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
orfolk and Norwich University Hospital NHS Trust (UK)

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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