None listed
Conditions
Brief summary
To evaluate, in overweight/obese patients with type 2 diabetes mellitus the chronic effects (24 months) of an energy restricted, very low carbohydrate (<50 g/day), low saturated fat (<10%) diet compared to an isocaloric high unrefined carbohydrate, low fat diet on: Primary outcomes: glycemic control, cardiovascular disease risk factors and endothelial function Secondary outcomes: weight loss, body composition, appetite, diet acceptance, renal/bone health.
Interventions
Very low carbohydrate, low saturated fat diet (N=75: 14% carbohydrate [<50 g carbohydrate/day], 28% protein, 58% fat). The overall duration of the study is 2 years (104 weeks).
The dietary pattern will be translated and consumed daily for the duration of the study in the form a dietary plan that incorporates freely available foods from the current food supply. This will include a breakfast, lunch and evening meal and snacks that will reflect the dietary composition described.
Sponsors
Commonwealth Scientific Industrial Research Organisation - Food and Nutritional Sciences
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Male or female Age between 35-65 years Body Mass Index not greater than 40 or less than 26 Have type 2 diabetes (HbA1c 7.0-9.0% or previously diagnosed and controlled with medication) Not have type 1 diabetes Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent No abnormality of clinical significance on medical history If female,not pregnant or breast feeding No history of coronary artery disease or cardiac (heart) abnormalities
Exclusion criteria
Body Mass Index greater than 40 or less than 26 Not have type 2 diabetes Lactose Intolerant Have proteinuria, a malignancy, abnormal liver function, any significant endocrinopathy, or a history of metabolic disease such as liver, kidney, cardiovascular, respiratory or gastrointestinal disease, cardiac (heart) abnormalities or are pregnant or lactating Have high uncontrolled hypertension (resting recumbent blood pressure greater than 160/100 mmHg) Have depression Have a musculoskeletal injury, joint or peripheral vascular disease sufficient to impede exercise (such as hip arthritis, foot, ankle problems or pain) Have severe exercise-induced asthma History of smoking during 6 months prior to study History of heavy alcohol consumption (more than 5 Standard drinks/day) Volunteer unable to limit alcohol consumption for study duration Participated in regular aerobic or resistance exercise program (greater than two 30-min sessions of moderate/vigorous aerobic exercise per week or greater than 1 moderate intensity resistance exercise session per week) during the 6 months prior to study Currently on a weight reducing diet or have an eating disorder Unwilling to be randomized to either experimental group Extended absences due to travel or other commitments Unable to comprehend or cope with study requirements
Outcome results
None listed