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NCT Number: NCT03536364

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

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.

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Key information

Conditions

Obesity Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre-diabetes Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Weight Control Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food Order

Behavioral

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

Other names: Carbohydrate First

Carbohydrate Last

Behavioral

protein and vegetables first, followed 10 minutes later by carbohydrate

Vegetables first

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 24, 2018
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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