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

NCT03536364 | Completed

• 1 other identifier: 1612017822
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Pre-Diabetes

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (3)

• 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

• 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

Study Arms (1)

Prediabetes

EXPERIMENTAL

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

Behavioral: Food Order; Behavioral: Carbohydrate Last; Behavioral: Vegetables first

Interventions

Food Order BEHAVIORAL

carbohydrate (ciabatta bread ) first, followed 10 minutes later by protein (grilled chicken) and vegetables

Also known as: Carbohydrate First

Prediabetes

Carbohydrate Last BEHAVIORAL

protein and vegetables first, followed 10 minutes later by carbohydrate

Prediabetes

Vegetables first BEHAVIORAL

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

Prediabetes

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Comprehensive Weight Control Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Obesity; Glucose Intolerance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Alpana P Shukla, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: May 24, 2018
• Study Start: March 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 24, 2018

Record last verified: 2018-05

Locations

US (1)