ong-term effect of altering the source and amount of dietary carbohydrate in type 2 diabetes

Completed

• Conditions: Diabetes mellitus; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN81151522
• Lead Sponsor: niversity of Toronto (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

1. Male or non-pregnant females
2. Aged 40 - 70 years old
3. Body mass index less than 40 kg/m^2
4. HbA1c less than or equal to 8.5%

Exclusion Criteria

1. Absence of diabetes
2. Age less than 40 years or greater than 70 years
3. Pregnancy or lactation
4. Body mass index greater than or equal to 40 kg/m^2
5. Use of any hypoglycaemic or anti-hyperglycaemic drug
6. HbA1c greater than 8.5%
7. Major cardiovascular event (stroke, myocardial infraction) or surgery within six months
8. Serum triglycerides greater than 10 mmol/l
9. Presence of other major debilitating disorder such as liver disease, renal failure, cancer
10. Presence of gastrointestinal disorder or use of a drug which is likely to alter gastrointestinal motility or nutrient absorption
11. Substance abuse
12. Simultaneous participation in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycated haemoglobin (A1c) measured at -2 and 0 weeks and at 3, 6, 9 and 12 months after randomisation (measure at 12 months is done twice; at 50 and 52 weeks).