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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536364
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Pre-Diabetes Behavioral: Food Order Behavioral: Carbohydrate Last Behavioral: Vegetables first Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Prediabetes
manipulation of food order during a meal on postprandial in subjects with prediabetes
Behavioral: Food Order
carbohydrate (ciabatta bread ) first, followed 10 minutes later by protein (grilled chicken) and vegetables
Other Name: Carbohydrate First

Behavioral: Carbohydrate Last
protein and vegetables first, followed 10 minutes later by carbohydrate

Behavioral: Vegetables first
vegetables first, followed 10 mins later by protein and carbohydrate.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536364


Locations
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United States, New York
Comprehensive Weight Control Center
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Alpana P Shukla, MD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03536364    
Other Study ID Numbers: 1612017822
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia