Metabolic education for new diabetics using energy restrictio

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN14900339
• Lead Sponsor: Optimum Health Innovations Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-31
• Study Completion: 2016-09-01
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified