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

NCT ID: NCT03536364

Last Updated: 2018-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2017-12-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prediabetes

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

Group Type: EXPERIMENTAL

Food Order

Intervention Type: BEHAVIORAL

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

Carbohydrate Last

Intervention Type: BEHAVIORAL

protein and vegetables first, followed 10 minutes later by carbohydrate

Vegetables first

Intervention Type: BEHAVIORAL

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

Interventions

Food Order

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

Intervention Type: BEHAVIORAL

Carbohydrate Last

protein and vegetables first, followed 10 minutes later by carbohydrate

Intervention Type: BEHAVIORAL

Vegetables first

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Carbohydrate First

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alpana P Shukla, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Comprehensive Weight Control Center

New York, New York, United States

Countries

United States

Other Identifiers

1612017822

Identifier Type: -

Identifier Source: org_study_id