ow glycaemic index diet for type 2 diabetics

Not Applicable

Completed

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

• Registration Number: ISRCTN01033037
• Lead Sponsor: St Michael's Hospital (Canada)

Brief Summary

1. 2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27388364 2. 2017 baseline data in: https://www.ncbi.nlm.nih.gov/pubmed/28336747

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-18
• Study Completion: 2016-08-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Current inclusion criteria as of 15/09/2016:
1. Type 2 diabetes diagnosed for greater than 6 months
2. Men and women aged over 21 years
3. Stable dose of hypoglycaemic medication
4. HbA1c between 6.5 and 8.0 at screening, and pre-study visit
5. Stable weight
6. Family physician and valid health card
7. Stable dose of lipid medication, if prescribed
8. Stable dose of blood pressure medication, if prescribed
9. Ability to keep written food records, use digital food scale

Previous inclusion criteria:
1. Type 2 diabetes dignosed for greater than 6 months
2. Men and post-menopausal women, aged over 21 years
3. Stable dose of hypoglycaemic medication
4. HbA1c between 6.5 and 8%
5. Stable weight
6. Family physician and valid health card
7. Stable dose of lipid medication, if prescribed
8. Stable dose of blood pressure medication, if prescribed
9. Ability to keep written food records, use digital food scale

Exclusion Criteria

1. Insulin, steroids, or warfarin
2. Gastrointestinal disease
3. Major cardiovascular event in past 6 months
4. Major surgery in past 6 months
5. Liver disease, hepatitis B or C
6. Renal failure
7. Major debilitating disorder
8. Serum triglycerides greater than 6 mmol/L
9. History of cancer (except non-melanoma skin cancer)
10. Pre-menopausal women
11. Food allergies to study foods
12. Blood pressure above 145/90 mmHg
13. Acute or chronic infections
14. Chronic inflammatory diseases
15. Inability to undergo magnetic resonance imaging (MRI)
16. Any other condition which make one unsuitable for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 15/09/2016:<br> Plaque volume, assessed by MRI at 1 and 3 years<br><br> Previous primary outcome measures:<br> 1. Carotid intima media thickness<br> 2. HbA1c<br> 3. Plasma glucose and lipids<br> Magnetic resonance imaging (MRI) of intima media will take place at 0, 1 year, and 3 years. Blood tests and clinic visits will take place every 3 months during the 3 years.<br>