Impaired Glucose Tolerance, Metabolic Syndrome, Type 2 Diabetes
Conditions
Keywords
Prediabetes, Type 2 diabetes, Metabolic syndrome, Insulin resistance syndrome, Weight loss, Milk products, Calcium
Brief summary
The purpose of this study is to determine if increased intake of low-fat milk products and calcium as part of a calorie restricted diet helps achieve a healthier body weight and body composition and decrease blood glucose levels in people with insulin resistance or type 2 diabetes.
Detailed description
Obesity can cause many health problems as it is linked to several chronic diseases including type 2 diabetes. We know that individuals who are overweight or obese, and have impaired glucose tolerance or insulin resistance, have a good chance of developing type 2 diabetes. Research tells us that the risk of developing type 2 diabetes can be decreased by losing weight and making dietary changes. A promising area of study involves using low-fat milk products and calcium to prevent and/or control obesity and diabetes. This study is important because it will determine if including low-fat milk products in weight reducing diets can enhance weight loss, improve fat loss and decrease levels of blood glucose and insulin in individuals with impaired glucose tolerance or type 2 diabetes not treated with medication. This information is directly applicable to treating diseases such as obesity, type 2 diabetes and heart disease.
Interventions
BEHAVIORALHigh dairy and calcium intake
High intake of low-fat milk product intake (3-4 servings per day) plus one 350 mg calcium supplement per day during 500 kcal/day deficit diet.
BEHAVIORALUsual intake
Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Overweight and obese (BMI of 27 to 37 kg/m2) * Impaired glucose tolerance (fasting blood glucose \>5.6 mmol/L) or * Type 2 diabetes treated with diet and exercise alone (no medications) * One or more of the following criteria for metabolic syndrome: 1. Hypertriglyceridemia (\> 1.70 mmol/L) 2. Low high-density lipoprotein (HDL) cholesterol (\< 1.04 mmol/L in men and \< 1.30 mmol/L in women) 3. High blood pressure (\> 130/85 mm Hg) 4. High waist circumference ( \> 94 cm in men, \> 80 cm in women) * Weight stable and no changes in exercise in past 3 months
Exclusion criteria
* Type 1 diabetes * Type 2 diabetes treated with oral hypoglycemic agents or insulin * HbA1c \> 8% * myocardial infarction or have undergone a cardiovascular intervention within the past three months * Subjects taking fibrate or statins who have had a dose change within the 8 weeks prior to randomization * Liver or pancreas disease * Major gastrointestinal surgeries * Pregnant or lactating * Exhibit alcohol or drug dependence * Taking drugs influencing appetite * Have a milk allergy or lactose intolerance * Following a diet or exercise regime designed for weight loss * Have a body weight greater than 350 lb (weight limit for DEXA instrument) * Chronic use of bulk laxatives, antacids or calcium supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Insulin and glucose response | 12 weeks |
| Inflammatory Markers | 12 weeks |
Countries
Canada
Outcome results
None listed