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Completed

NCT Number: NCT04738799

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Carbohydrate-Last Meal Sequence

Behavioral

Carbohydrates consumed last during mealtimes for 6 days

Carbohydrate-First Meal Sequence

Behavioral

Carbohydrates consumed first during mealtimes for 6 days

Primary outcomes

  1. Change in incremental glucose peak, under controlled conditions

    Time frame: Day 6, Day 12

  2. Change in mean amplitude of glycemic excursion, under controlled conditions

    Time frame: Day 6, Day 12

  3. Change in time in range, under controlled conditions

    Time frame: Day 6, Day 12

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

Secondary outcomes

  1. Change in incremental glucose peak, under free-living conditions

    Time frame: Day 1 through 5, Day 7 through 11

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

    Time frame: Day 1 through 5, Day 7 through 11

  3. Change in time in range, under free-living conditions

    Time frame: Day 1 through 5, Day 7 through 11

    Time during which participant maintained a blood glucose level between 70-180mg/dL

  4. Change in postprandial insulin concentration

    Time frame: Day 6, Day 12

    Postprandial concentrations of insulin measured at 30-minute intervals for 180 minutes following standardized meal administration.

  5. Change in postprandial c-peptide concentration

    Time frame: Day 6, Day 12

    Postprandial concentrations of c-peptide measured at 30-minute intervals for 180 minutes following standardized meal administration.

  6. Change in postprandial ghrelin concentration

    Time frame: Day 6, Day 12

    Postprandial concentrations of ghrelin measured at 30-minute intervals for 180 minutes following standardized meal administration.

  7. Change in postprandial PYY concentration

    Time frame: Day 6, Day 12

    Postprandial concentrations of PYY measured at 30-minute intervals for 180 minutes following standardized meal administration.

  8. Change in postprandial GLP-1 concentration

    Time frame: Day 6, Day 12

    Postprandial concentrations GLP-1 measured at 30-minute intervals for 180 minutes following standardized meal administration.

  9. Change in postprandial CCK concentration

    Time frame: Day 6, Day 12

    Postprandial concentrations of CCK measured at 30-minute intervals for 180 minutes following standardized meal administration.

  10. Change in satiety, as measured by Visual Analog Scale (VAS)

    Time frame: Day 6, Day 12

    Scores are measured on a 100mm VAS. The VAS ranges from 0 to 100, with 0 indicating lower satiety and higher scores indicating greater satiety.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2021
Registry last updated
Oct 30, 2023

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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