Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes
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About
The natural history of type 2 diabetes commonly follows a pattern of postprandial dysregulation followed by fasting hyperglycemia leading to overt type 2 diabetes. Approximately 38% of the US adult population is estimated to have pre-diabetes. In a previous study of 16 overweight/obese patients with metformin treated type 2 diabetes, using a typical Western meal, investigators demonstrated that a food order in which protein and vegetables are consumed first, before carbohydrate, results in significant lowering of incremental glucose peaks compared to the reverse order. In the present study, investigators seek to expand on the previous findings to gain further insight into the impact of food order in individuals with pre-diabetes, using a meal with different macronutrient composition, in the setting of three meal patterns. The study is designed to be a simple, practical intervention that may have very significant clinical implications for prevention of diabetes in a large population at increased metabolic risk.
Enrollment
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Ages
Volunteers
Inclusion criteria
- Male and female subjects between 30-65 years of age
- BMI 25-40kg/m2
- HbA1c 5.7%-6.4%
- Willing to comply with study requirements
- Provide written informed consent
Exclusion criteria
- Known diagnosis of diabetes / taking any medication for treatment of diabetes
- History of previous bariatric surgery
- History of chronic liver or renal disease
- Current treatment with systemic corticosteroids
- Pregnant women
- History of allergy to any component of the test meal
Trial design
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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