Diabetes, Prediabetes
Conditions
Keywords
Diabetes, Prediabetes, Prevention, Whole grain, Advanced glycation end products, Insulin sensitivity
Brief summary
Food products derived from cereal grains constitute a major part of the daily diet of many Americans . For example, a typical Chinese American eats rice about 9.5 times a week on an average. However, most of these foods are derived from refined grain. During the refining process grains are stripped of their bran and germ which results in depletion of several biologically active constituents including fiber, anti-oxidants, phytoestrogens and minerals. From observational studies there is evidence for a protective effect of whole-grain foods with regard to the development of type 2 diabetes. More recently, higher intake of whole grains was also associated with decreases in insulin resistance - a risk factor related to the development of type 2 diabetes. In this randomized study the investigators plan to replicate this beneficial effect of improving insulin sensitivity in patients with pre-diabetes and go a step further by exploring the potential mechanisms by which this benefit may occur. The investigators will assess the effect of consuming a whole-grain-rich diet on levels of advanced glycation endproducts (AGE), RAGE (receptor for AGE) and markers of inflammation and oxidative stress - all of which have been shown to play an important role in the pathogenesis of diabetes mellitus. The investigators will also look for correlations between the levels of these markers with insulin sensitivity to identify potential mechanisms of pathogenesis.
Interventions
OTHERWhole grain rice
Whole grain rice arm (treatment arm): Subjects will be provided a supply of whole grain rice and will be asked to prepare rice items in their meal with the provided whole grain rice while participating in the study
OTHERRefined grain rice
Refined grain rice arm (control arm): Subjects will be provided a supply of refined grain rice and will be asked to prepare rice items in their meal with the provided refined grain rice while participating in the study
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years to unlimited, both genders. 2. At least one meal per day included rice in the seven days prior to enrolment. 3. No current diagnosis of Diabetes Mellitus (DM). 4. Fasting blood glucose value between 100 to 125 mg/dl and/or Hemoglobin A1c levels between 5.7%-6.4%. 5. ≥ 2 visits with primary care physician to establish compliance
Exclusion criteria
1. Special diets (e.g. vegetarian) 2. Use of medications that would affect blood sugar levels (e.g. steroids) 3. Allergy to any type of grain 4. Body weight fluctuation over the past 180 days of ≥ 10% 5. Planning to significantly change level of physical activity during the time of study. 6. Planning to move out of town or take a vacation for ≥ 14 days during the time of the study 7. Current smoker 8. Consumption of greater than 2 alcoholic drinks per day 9. History of malignancy and overt cardiovascular disease (apart from hypertension).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Homeostatic Model Assessment (HOMA) Index | 0 | Estimates insulin resistance and β-cell function from fasting glucose and insulin levels |
| Homeostatic model assessment(HOMA) index | 6 weeks | Estimates insulin resistance and β-cell function from fasting glucose and insulin levels |
| Homeostatic model assessment (HOMA) index. | 12 weeks | Estimates insulin resistance and β-cell function from fasting glucose and insulin levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Receptor for advanced glycation endproducts (RAGE) | 0, 6 and 12 weeks | Receptor for advanced glycation endproducts |
| Carboxymethyl lysine (CML) | 0, 6 and 12 weeks | Advanced glycation end product (in blood and urine) |
| Sirtuin 1 | 0, 6 and 12 weeks | A protein that in humans is encoded by the SIRT1 gene and regulates processes such as apoptosis and muscle differentiation by deacetylating key proteins. It is down regulated in cells that have high insulin resistance and inducing its expression increases insulin sensitivity |
| Methylglyoxal (MG) | 0, 6 and 12 weeks | Advanced glycation end product (in blood and urine) |
| IL-6 | 0, 6 and 12 weeks | Inflammatory marker |
Countries
United States
Outcome results
None listed