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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2017

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Prediabetes
    • manipulation of food order during a meal on postprandial in subjects with prediabetes

Clinical Trial Outcome Measures

Primary 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
    • Time Frame: 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
    • Time Frame: 30, 60, 90, 120, 150 and 180 mins
  • 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 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
    • Time Frame: 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
    • Time Frame: 0-180 mins
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Weill Medical College of Cornell University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alpana P Shukla, MD, Principal Investigator, Weill Medical College of Cornell University

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