The European Diabetes Prevention Study

Reducing the burden of non-insulin dependent diabetes mellitus: a randomised controlled trial of behavioural interventions to modify diet and physical activity in people with impaired glucose tolerance Also from June 2011: A follow-up at 10 years of participants in the Newcastle Arm of the European Diabetes Prevention Study who remain free of type 2 diabetes at 10 years from baseline, based of diagnoses from within the trial or subsequent General Practitioner diagnoses: to assess the difference in incidence of type 2 diabetes between the intervention and control arms of the original study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15670600

Enrollment

104

Registered

2005-10-14

Start date

2000-07-20

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Nutritional, Metabolic, Endocrine Diabetes

Interventions

The study is a parallel design, randomised controlled study with one intervention arm and one control arm. Individuals with IGT are randomly allocated to receive either intensive behavioural intervent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Have IGT, defined as a mean two-hour plasma glucose value more than 7.8 and less than 11.1 mmol/l from two Oral Glucose Tolerance Tests (OGTTs), the second conducted one to 12 weeks after the first 2. Be aged 40 to 74 years on their last birthday, either sex 3. Be overweight (Body Mass Index [BMI] more than 25 kg/m^2)

Exclusion criteria

Exclusion criteria: 1. Previous diagnosis of diabetes according to World Health Organisation (WHO) 1999 criteria 2. Previous intensive treatment for IGT 3. Previous participation in a programme of vigorous physical activity

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 26/01/2009: Incidence of diabetes confirmed by two OGTTs (between one and 12 weeks apart). Previous primary outcome measure: Changes in new diabetes confirmed on two OGGTs	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 26/01/2009: Changes in: 1. Weight 2. Physical activity 3. Dietary fibre intake 4. Carbohydrate intake as a percentage of total dietary energy 5. Fat intake as a percentage of total dietary energy Previous secondary outcome measures: 1. The proportion of energy consumed from fat, protein, carbohydrates and saturated, monounsaturated, polyunsaturated fatty acids, fibre and cholesterol 2. Physical activity 3. Glucose tolerance 4. Insulin sensitivity 5. Cardiovascular risk factors 6. Cardiovascular morbidity and mortality 7. Quality of life	—

Measure

Time frame

Current secondary outcome measures as of 26/01/2009: Changes in: 1. Weight 2. Physical activity 3. Dietary fibre intake 4. Carbohydrate intake as a percentage of total dietary energy 5. Fat intake as a percentage of total dietary energy Previous secondary outcome measures: 1. The proportion of energy consumed from fat, protein, carbohydrates and saturated, monounsaturated, polyunsaturated fatty acids, fibre and cholesterol 2. Physical activity 3. Glucose tolerance 4. Insulin sensitivity 5. Cardiovascular risk factors 6. Cardiovascular morbidity and mortality 7. Quality of life

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026