Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes

Study Overview
=================
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.

Official Title
-----------------
Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes

Conditions
-----------------
Obesity, Pre-Diabetes

Intervention / Treatment
-----------------
* Behavioral: Food Order
* Behavioral: Carbohydrate Last
* Behavioral: Vegetables first


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prediabetes<br>manipulation of food order during a meal on postprandial in subjects with prediabetes | Behavioral: Food Order<br>* carbohydrate (ciabatta bread ) first, followed 10 minutes later by protein (grilled chicken) and vegetables<br>* Other names: Carbohydrate First;Behavioral: Carbohydrate Last<br>* protein and vegetables first, followed 10 minutes later by carbohydrate<br>Behavioral: Vegetables first<br>* vegetables first, followed 10 mins later by protein and carbohydrate.<br>|

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

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |