Metabolic education for new diabetics using energy restriction

Pilot for interventional diabetes self-management education service

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14900339

Enrollment

Registered

2016-05-31

Start date

2016-06-01

Completion date

Unknown

Last updated

2021-05-03

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

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

The proposed study intends to bring together diabetes self-management education aligned with current standards, personal data tracking of the components of the energy balance equation (weight, activit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =18-75 years old 2. A confirmed diagnosis of T2DM within the last year treated by metformin and/or lifestyle 3. A body mass index of 22-45 kg/m2 4. Willingness to undertake a structured education programme for 6 weeks 5. Willingness to attend the course venue at specified times on 6 separate occasions 6. Ability to read, write and converse in English without the support of an interpreter 7. Familiar with internet and Smartphone use and with regular access to a connected computer

Exclusion criteria

Exclusion criteria: 1. Inability to provide informed consent 2. Unwillingness or inability to perform any of the study components required, specifically self-monitoring of blood glucose (finger-stick SMBG) or oral glucose tolerance test (OGTT) 3. Any contra-indication for weight loss 4. Type 1 diabetes mellitus (T1DM) or diagnosed with T2DM > 1 years 5. Currently prescribed insulin, thiazolidenediones or sulfonylurea. 6. Currently prescribed steroids or beta-blockers 7. Serum Creatinine > 150mmol/L 8. Serum ALT greater than 2.5 times the upper limit of the reference range 9. Pregnant or intending to become pregnant 10. HF or any other existing cardiovascular co-morbidity 11. Currently participating in any weight loss or lifestyle modification trial

Design outcomes

Primary

Measure	Time frame
1. Area under 2-hour oral glucose tolerance curve pre and post energy restriction 2. Health Education Impact Questionnaire score pre and post energy restriction	—

Secondary

Measure	Time frame
1. Fasting blood glucose pre and post energy restriction 2. Body composition pre and post energy restriction	—

Countries

United Kingdom

Contacts

Public ContactJames Troke

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026