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

Primary Purpose

Obesity, Pre-Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Order
Carbohydrate Last
Vegetables first
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Weight Control Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prediabetes

Arm Description

manipulation of food order during a meal on postprandial in subjects with prediabetes

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
March 23, 2018
Last Updated
May 14, 2018
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT03536364
Brief Title
Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes
Official Title
Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pre-Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prediabetes
Arm Type
Experimental
Arm Description
manipulation of food order during a meal on postprandial in subjects with prediabetes
Intervention Type
Behavioral
Intervention Name(s)
Food Order
Other Intervention Name(s)
Carbohydrate First
Intervention Description
carbohydrate (ciabatta bread ) first, followed 10 minutes later by protein (grilled chicken) and vegetables
Intervention Type
Behavioral
Intervention Name(s)
Carbohydrate Last
Intervention Description
protein and vegetables first, followed 10 minutes later by carbohydrate
Intervention Type
Behavioral
Intervention Name(s)
Vegetables first
Intervention Description
vegetables first, followed 10 mins later by protein and carbohydrate.
Primary Outcome Measure Information:
Title
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
Time Frame
30, 60, 90, 120, 150 and 180 mins
Title
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
Time Frame
30, 60, 90, 120, 150 and 180 mins
Title
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
Time Frame
0-180 min
Secondary Outcome Measure Information:
Title
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
Time Frame
30, 60, 90, 120, 150 and 180 mins
Title
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
Time Frame
0-180 mins
Title
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
Time Frame
0,60,120, and 180 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alpana P Shukla, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Weight Control Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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

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