Dairy Products, Diabetes and Genetics

Study Overview
=================
Brief Summary
-----------------
This study will investigate the in-depth the benefits of dairy consumption on glucose metabolism in patients at risk of type 2 diabetes using novel genomics methodology.To do so, 33 individuals at risk of type 2 diabetes will be randomly subjected to an intervention study including a 6-week intensive dairy product consumption period and a 6-week dietary counselling period.

Detailed Description
-----------------
More than 9 million Canadians are living with diabetes or prediabetes. Type 2 diabetes is a disorder characterized by high blood glucose. Dietary modification is a key component in type 2 diabetes management. For example, dairy product consumption has beneficial effects on metabolic health. Yet, researchers have shown that mixed results exists for insulin sensitivity.

Official Title
-----------------
Nutrigenomics Approach to Investigate the Benefits of Dairy Product Consumption on Glucose Homeostasis

Conditions
-----------------
Insulin Sensitivity, Type2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Increased dairy product
* Behavioral: Dietary counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian men and postmenopausal women (absence of menstrual cycles for >12 months) aged >18 yrs; BMI between 25-40 kg/m2; Hyperinsulinemia (fasting plasma insulin >90 pmol/l); Fasting plasma glucose (FPG) <7.0 mmol/l; HbA1c <6.5%); If treated with lipid-lowering agents, the dose must have been stable over the last 3 months; Stable body weight (±5%) for 3 months; Willing to consume study foods and able to follow protocol and give informed consent. Exclusion Criteria: Failure to meet any one or more of the inclusion criteria; Diagnosis of type 2 diabetes; High dairy consumption ( 2 servings/day or more); Major surgery in the 3 months prior to study onset; Smoking; Incompatibility with dairy consumption (allergy, intolerance or dislike); Inflammatory bowel disease or other gastrointestinal disorder influencing gastrointestinal motility or nutrient absorption; Medications known to affect lipid and glucose metabolism other than those used to treat hypertension or dyslipidemia; Diseases known to affect glucose metabolism.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Increased dairy product<br>Subjects will be asked to consume a total of 3 to 5 servings per day.They will be instructed on options and variations for incorporating the dairy foods into their routine dietary pattern. | Behavioral: Increased dairy product<br> <br> |
| Placebo Comparator: Dietary counselling<br>Subjects will review the standard dietary recommendation(http://www.diabetes.ca/diabetes-and-you/nutrition/meal-planning-guide/) by a registered dietitian. | Behavioral: Dietary counselling<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases | 2h-oral glucose tolerance test (OGTT) | Change from 0 to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 6 weeks in fasting glucose between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in 2 h plasma glucose post OGTT between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in insulin secretion (Insulinogenic index ) between high dairy and dietary counselling phases | Insulinogenic index | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in insulin secretion (area under the curve of C-peptide) between high dairy and dietary counselling phases | Area under the curve of C-peptide | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in b-cell function (disposition index) between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in glucagon-like peptide-1 secretion between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in fat mass between high dairy and dietary counselling phases | Dual-energy X-ray absorptiometry | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in blood pressure between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in aortic stiffness (pulse wave velocity) between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in lipid profile (total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in inflammatory profile (C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6) between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in oxidative stress profile (F2-isoprostane profiles) between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in fatty acid profile between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in serum 25(OH) vitamin D between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in gene expression profiles between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks | 
| Change from baseline to 6 weeks in metabolomics profiles between high dairy and dietary counselling phases |  | Change from 0 to 6 weeks |