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

• ClinicalTrials.gov Identifier: NCT03536364
• Recruitment Status: Completed
• First Posted: May 24, 2018
• Last Update Posted: May 24, 2018
• Sponsor: Weill Medical College of Cornell University
• Information provided by (Responsible Party): Weill Medical College of Cornell University

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.

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Alpana P Shukla, MD; Weill Medical College of Cornell University

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03536364
• Other Study ID Numbers: 1612017822
• First Posted: May 24, 2018
• Last Update Posted: May 24, 2018
• Last Verified: May 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Prediabetic State; Glucose Intolerance; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia