NCT00318032

Brief Summary

Diabetes is a common chronic condition associated with the risk of heart disease, and eye and kidney damage. Many people are diagnosed with diabetes when they develop symptoms or complications, suggesting that the true onset of disease occurs years earlier. Early detection of diabetes may result in health benefits, but this is not proven. People of South Asian origin are at more risk of having diabetes and of getting the heart disease complications associated with it. The study aims to test whether screening for diabetes is feasible in a South Asian population and to measure the benefits of early detection and intensive treatment. Hypothesis: A program of screening and an intensive multi-factorial intervention for type 2 diabetes is both feasible and cost effective within primary care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,579

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2006

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 25, 2006

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

July 2, 2014

Status Verified

July 1, 2014

Enrollment Period

11.3 years

First QC Date

January 23, 2006

Last Update Submit

July 1, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

Randomised control trialScreeningIntensive managementDiabetes mellitusType 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • To contribute to the ADDITION-Europe study, to assess screening and intensive treatment on 5 year cardiovascular outcomes

    At end of study

Secondary Outcomes (2)

  • To assess the feasibility of screening in a South Asian population and the effect of intensive treatment in people with screen detected diabetes on modelled cardiovascular risk at 1 year

    At end of study

  • To assess the economic and psychological cost of screening

    At end of study

Study Arms (1)

Intensive Treatment

OTHER

Frequent specialised diabetes clinician contact. DESMOND self-management programme

Drug: multi-factorial intervention

Interventions

multi-factorial interventionDRUG
Intensive Treatment

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will be included into the study will be from the following groups:
  • White European subjects aged between 40-75 years
  • Asian, Black, or Chinese subjects aged between 25-75 years

You may not qualify if:

  • Patients will be excluded from the study if they:
  • Are housebound
  • Have a terminal illness
  • Have diabetes mellitus
  • Have an active psychotic illness which deems them unable to give informed consent.
  • Are pregnant or lactating
  • Are taking part in any other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leicester, Leicester Royal Infirmary

Leicester, Leicestershire, LE4 0AW, United Kingdom

Location

Related Publications (10)

  • Peer N, Balakrishna Y, Durao S. Screening for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 May 29;5(5):CD005266. doi: 10.1002/14651858.CD005266.pub2.

    PMID: 32470201DERIVED

  • Webb D, Dales J, Zaccardi F, Hill S, Moore C, Farooqi A, Griffin S, Davies M, Khunti K. Intensive versus standard multifactorial cardiovascular risk factor control in screen-detected type 2 diabetes: 5-year and longer-term modelled outcomes of the ADDITION-Leicester study. Diabetes Metab Res Rev. 2019 Mar;35(3):e3111. doi: 10.1002/dmrr.3111. Epub 2018 Dec 19.

    PMID: 30521699DERIVED

  • Kidy FF, Dhalwani N, Harrington DM, Gray LJ, Bodicoat DH, Webb D, Davies MJ, Khunti K. Associations Between Anthropometric Measurements and Cardiometabolic Risk Factors in White European and South Asian Adults in the United Kingdom. Mayo Clin Proc. 2017 Jun;92(6):925-933. doi: 10.1016/j.mayocp.2017.02.009.

    PMID: 28578782DERIVED

  • Bodicoat DH, O'Donovan G, Dalton AM, Gray LJ, Yates T, Edwardson C, Hill S, Webb DR, Khunti K, Davies MJ, Jones AP. The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study. BMJ Open. 2014 Dec 23;4(12):e006076. doi: 10.1136/bmjopen-2014-006076.

    PMID: 25537783DERIVED

  • Mostafa SA, Davies MJ, Morris DH, Yates T, Srinivasan BT, Webb D, Brady E, Khunti K. The association of the triglyceride-to-HDL cholesterol ratio with insulin resistance in White European and South Asian men and women. PLoS One. 2012;7(12):e50931. doi: 10.1371/journal.pone.0050931. Epub 2012 Dec 10.

    PMID: 23251403DERIVED

  • Mostafa SA, Khunti K, Kilpatrick ES, Webb D, Srinivasan BT, Gray LJ, Davies MJ. Diagnostic performance of using one- or two-HbA1c cut-point strategies to detect undiagnosed type 2 diabetes and impaired glucose regulation within a multi-ethnic population. Diab Vasc Dis Res. 2013 Jan;10(1):84-92. doi: 10.1177/1479164112451473. Epub 2012 Jul 6.

    PMID: 22773521DERIVED

  • Mostafa SA, Davies MJ, Webb DR, Srinivasan BT, Gray LJ, Khunti K. Independent effect of ethnicity on glycemia in South Asians and white Europeans. Diabetes Care. 2012 Aug;35(8):1746-8. doi: 10.2337/dc11-2079. Epub 2012 Jun 14.

    PMID: 22699291DERIVED

  • Gray LJ, Yates T, Davies MJ, Brady E, Webb DR, Sattar N, Khunti K. Defining obesity cut-off points for migrant South Asians. PLoS One. 2011;6(10):e26464. doi: 10.1371/journal.pone.0026464. Epub 2011 Oct 19.

    PMID: 22039493DERIVED

  • Webb DR, Gray LJ, Khunti K, Srinivasan B, Taub N, Campbell S, Barnett J, Farooqi A, Echouffo-Tcheugui JB, Griffin SJ, Wareham NJ, Davies MJ. Screening for diabetes using an oral glucose tolerance test within a western multi-ethnic population identifies modifiable cardiovascular risk: the ADDITION-Leicester study. Diabetologia. 2011 Sep;54(9):2237-46. doi: 10.1007/s00125-011-2189-2. Epub 2011 Jun 3.

    PMID: 21638133DERIVED

  • Webb DR, Khunti K, Srinivasan B, Gray LJ, Taub N, Campbell S, Barnett J, Henson J, Hiles S, Farooqi A, Griffin SJ, Wareham NJ, Davies MJ. Rationale and design of the ADDITION-Leicester study, a systematic screening programme and randomised controlled trial of multi-factorial cardiovascular risk intervention in people with type 2 diabetes mellitus detected by screening. Trials. 2010 Feb 19;11:16. doi: 10.1186/1745-6215-11-16.

    PMID: 20170482DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Melanie J Davies, MD

    University Hospitals, Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2006

First Posted

April 25, 2006

Study Start

August 1, 2004

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 2, 2014

Record last verified: 2014-07

Locations

GB(1)