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

Not Applicable

Completed

• Conditions: Pre-Diabetes; Obesity
• Interventions: Behavioral: Food Order; Behavioral: Carbohydrate Last; Behavioral: Vegetables first

• Registration Number: NCT03536364
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-10-01
• Study Completion: 2017-12-01
• Study First Submitted: 2018-03-23
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-14
• Last Update Submitted: 2018-05-14
• Study First Posted: 2018-05-24
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prediabetes	Carbohydrate Last	manipulation of food order during a meal on postprandial in subjects with prediabetes
Prediabetes	Food Order	manipulation of food order during a meal on postprandial in subjects with prediabetes
Prediabetes	Vegetables first	manipulation of food order during a meal on postprandial in subjects with prediabetes

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Comprehensive Weight Control Center; 🇺🇸 New York, New York, United States