NCT04738799

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 29, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

January 31, 2021

Last Update Submit

October 27, 2023

Conditions

Type 2 Diabetes

Keywords

diabetesnutrient sequencefood ordercontinuous glucose monitoringcgmt2dmglycemic excursionglp-1ghrelininsulincckpyyc-peptidemetformindiet

Outcome Measures

Primary Outcomes (3)

  • Change in incremental glucose peak, under controlled conditions

    Day 6, Day 12

  • Change in mean amplitude of glycemic excursion, under controlled conditions

    Day 6, Day 12

  • Change in time in range, under controlled conditions

    Time during which participant maintained a blood glucose level between 70-180mg/dL over 8 hour observation period

    Day 6, Day 12

Secondary Outcomes (10)

  • Change in incremental glucose peak, under free-living conditions

    Day 1 through 5, Day 7 through 11

  • Change in mean amplitude of glycemic excursion, under free-living conditions

    Day 1 through 5, Day 7 through 11

  • Change in time in range, under free-living conditions

    Day 1 through 5, Day 7 through 11

  • Change in postprandial insulin concentration

    Day 6, Day 12

  • Change in postprandial c-peptide concentration

    Day 6, Day 12

  • +5 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: Carbohydrate-Last Meal SequenceBehavioral: Carbohydrate-First Meal Sequence

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

EXPERIMENTAL

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.

Behavioral: Carbohydrate-Last Meal SequenceBehavioral: Carbohydrate-First Meal Sequence

Interventions

Carbohydrate-Last Meal SequenceBEHAVIORAL

Carbohydrates consumed last during mealtimes for 6 days

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

Carbohydrates consumed first during mealtimes for 6 days

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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Alpana Shukla, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to continuous glucose monitoring readings.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 4, 2021

Study Start

April 29, 2021

Primary Completion

July 3, 2023

Study Completion

July 3, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)