Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
02/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Linda Carter

ORCID ID

Contact details

Diabetes and Endocrinology
Nutrition & Dietetics
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 (0)20 8846 1445
Lcarter@hhnt.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016132018

Study information

Scientific title

Investigation into the effect of intensive dietary intervention on post prandial glycaemic control and perception of risk of developing diabetes in women with a history of gestational diabetes

Acronym

Study hypothesis

1. To examine the effects of an intensive dietary intervention on post prandial blood glucose profiles (and first phase insulin response).
2. To examine the effects of that dietary education programme on perception of risk and ability to influence the risk of developing diabetes for women with a history of gestational diabetes.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Nutritional, Metabolic, Endocrine: Diabetes

Intervention

Randomised controlled trial of a dietary education programme.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The intervention aims to improve post prandial glycaemic control and insulin response hence reducing the risk or delaying the onset of Type 2 diabetes. The study will investigate whether the risk of developing Type 2 diabetes can be reduced by using intensive dietetic strategy, originally developed as an intensive weight management service within the diabetes framework.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

28/08/2003

Overall trial end date

27/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Females aged 18-50 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

28/08/2003

Recruitment end date

27/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Charing Cross Hospital
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Hammersmith Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/11/2016: No publications found, verifying study status with principal investigator.