The Impact of Food Order on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring

NCT ID: NCT04738799

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-29

Study Completion Date

2023-07-03

Brief Summary

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The purpose of this study is to explain the effect of food order/nutrient sequencing on glycemic excursions over a 2 week period, utilizing a device known as a continuous glucose monitor (CGM), for people who have been diagnosed with Type 2 Diabetes Mellitus and treated with metformin. This research study is being done because recent studies demonstrate that besides carbohydrate amount and type, the sequential order of macronutrient consumption during a meal has a significant impact on post-meal glucose levels.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be blinded to continuous glucose monitoring readings.

Study Groups

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Carbohydrate-Last Meal Sequence, Then Carbohydrate-First Meal Sequence

Participants will consume the carbohydrate portion of their prepared meals last during mealtimes for 6 days. They will then consume the carbohydrate portion of their prepared meals first during mealtimes for the following 6 days.

Group Type EXPERIMENTAL

Carbohydrate-Last Meal Sequence

Intervention Type BEHAVIORAL

Carbohydrates consumed last during mealtimes for 6 days

Carbohydrate-First Meal Sequence

Intervention Type BEHAVIORAL

Carbohydrates consumed first during mealtimes for 6 days

Carbohydrate-First Meal Sequence, Then Carbohydrate-Last Meal Sequence

Participants will consume the carbohydrate portion of their prepared meals first during mealtimes for 6 days. They will then consume the carbohydrate portion of their prepared meals last during mealtimes for the following 6 days.

Group Type EXPERIMENTAL

Carbohydrate-Last Meal Sequence

Intervention Type BEHAVIORAL

Carbohydrates consumed last during mealtimes for 6 days

Carbohydrate-First Meal Sequence

Intervention Type BEHAVIORAL

Carbohydrates consumed first during mealtimes for 6 days

Interventions

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Carbohydrate-Last Meal Sequence

Carbohydrates consumed last during mealtimes for 6 days

Intervention Type BEHAVIORAL

Carbohydrate-First Meal Sequence

Carbohydrates consumed first during mealtimes for 6 days

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Metformin-treated type 2 diabetes of less than 10 years duration
* Must be on a stable dose of metformin for at least 1 month
* HbA1c ≤8.5 percent

Exclusion Criteria

* Relevant food allergies
* Oral steroid therapy within 90 days of enrollment
* Anti-diabetic medications other than metformin
* History of bariatric surgery
* Pregnant women
* Any participant deemed unsuitable in the investigator's opinion
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alpana Shukla, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20-03021613

Identifier Type: -

Identifier Source: org_study_id

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