Obesity, Pre-Diabetes
Conditions
Brief summary
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.
Interventions
BEHAVIORALFood Order
carbohydrate (ciabatta bread ) first, followed 10 minutes later by protein (grilled chicken) and vegetables
BEHAVIORALCarbohydrate Last
protein and vegetables first, followed 10 minutes later by carbohydrate
BEHAVIORALVegetables first
vegetables first, followed 10 mins later by protein and carbohydrate.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female subjects between 30-65 years of age 2. BMI 25-40kg/m2 3. HbA1c 5.7%-6.4% 4. Willing to comply with study requirements 5. Provide written informed consent
Exclusion criteria
1. Known diagnosis of diabetes / taking any medication for treatment of diabetes 2. History of previous bariatric surgery 3. History of chronic liver or renal disease 4. Current treatment with systemic corticosteroids 5. Pregnant women 6. History of allergy to any component of the test meal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of food order on postprandial glucose excursions as measured by incremental glucose peaks (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes | 30, 60, 90, 120, 150 and 180 mins |
| Effect of food order on postprandial glucose excursions as measured by post prandial glucose levels (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes | 30, 60, 90, 120, 150 and 180 mins |
| Effect of food order on postprandial glucose excursions as measured by incremental area under the curve (iAUC) for glucose ((mg/dl)*180) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes | 0-180 min |
Secondary
| Measure | Time frame |
|---|---|
| Effect of food order on postprandial insulin levels (microIU/ml) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes | 30, 60, 90, 120, 150 and 180 mins |
| Effect of food order on postprandial insulin incremental area ((microIU/ml)*180min) under the curve in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes | 0-180 mins |
| Effect of food order on satiety as measured by a visual analog scale (cm) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes | 0,60,120, and 180 mins |
Countries
United States
Outcome results
None listed