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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536364
• Other study ID #: 1612017822
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: May 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Obesity
• Pre-Diabetes
• Prediabetic State

Intervention

Behavioral:
• Food Order
carbohydrate (ciabatta bread ) first, followed 10 minutes later by protein (grilled chicken) and vegetables
• Carbohydrate Last
protein and vegetables first, followed 10 minutes later by carbohydrate
• Vegetables first
vegetables first, followed 10 mins later by protein and carbohydrate.

Locations

Country	Name	City	State
United States	Comprehensive Weight Control Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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