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Completed

NCT Number: NCT00223574

Canadian Trial of Dietary Carbohydrates in Diabetes

A long-term low carbohydrate, high monounsaturated fat diet, compared to a high carbohydrate, low glycemic index diet, results in more rapid progression of diabetes; i.e. increased fasting glucose and glycated hemoglobin, reduced beta-cell function and insulin sensitivity and increased free fatty acids. The deleterious effects of a high carbohydrate diet on plasma lipids are only temporary and do not persist beyond 6 months. A long-term high carbohydrate, low glycemic index diet, compared to a high carbohydrate, high glycemic index diet, improves glycemic control and beta-cell function

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trials Centre, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or non-pregnant/non-lactating females with type 2 diabetes treated by diet alone
  • age 53-75y
  • body mass index 25-40kg/m^2 (Caucasian) or 23-40kg/m^2 (other)
  • HbA1c <=130% of upper limit of normal of local hospital lab

Exclusion criteria

  • use of any hypoglycemic or anti-hyperglycemic drug within 6 months of randomization
  • major cardiovascular event or major surgery within 6 months of randomization
  • serum triglycerides >10mmol/L
  • presence of other major debilitating disorder such as liver disease, renal failure or cancer
  • presence of gastrointestinal disorder or use of drug which is likely to alter gastrointestinal motility or nutrient absorption
  • use of oral steroids
  • substance or alcohol abuse
  • simultaneous participation in another clinical trial
  • allergy or intolerance to more than one of wheat, barley, corn, oats, potato, legumes, nuts, psyllium, olives, avocado or canola
  • unwilling or unable to follow the protocol and/or give informed consent
  • subjects planning to be on holiday for more than 8 weeks in a row or a total of 12 weeks in the year in locations to which they will not take study food

Treatment and study plan

Control - high carbohydrate, high glycemic index foods

Drug

high carbohydrate, low glycemic index foods

Drug

low carbohydrate, high monounsaturate fat foods

Drug

Primary outcomes

  1. glycated hemoglobin

Secondary outcomes

  1. Body weight

  2. waist circumference

  3. occurrence of diet failure

  4. fasting glucose

  5. fasting C-reactive protein

  6. fasting lipids (total, HDL and LDL cholesterol and triglcyerides)

  7. fasting apolipoproteins A1 and B100

  8. fasting free fatty acids

  9. fasting short chain fatty acids

  10. plasma glucose and insulin 30, 60 and 120min after 75g oral glucose

  11. insulin sensitivity (HOMA)

  12. beta-cell function (30min-fasting insulin)/(30min-fasting glucose)

  13. metabolic profile (glucose, insulin, triglycerides and FFA during 8h profile)

  14. quality of life

  15. gastrointestinal symptoms

  16. diet satisfactio

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

Long-Term Effect of Altering the Source or Amount of Dietary Carbohydrate in Type 2 Diabetes

Important dates

Study start
2002
Study completion
2004
First posted
Sep 22, 2005
Registry last updated
Sep 22, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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