Glycemic Effects of Meals - Repeatability Trial With Continuous Glucose Monitoring

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University

About this trial

Almost half of adults in the United States have either diabetes mellitus (DM) or prediabetes (preDM), but many are undiagnosed and unaware of their condition. Current DM diagnosis and risk prediction are based on single "snapshot" measurements including: fasting blood glucose, postprandial glucose, and hemoglobin (Hb)A1c. Continuous glucose monitoring (CGM) offers a dynamic view of glucose levels throughout the day which enables characterizing individuals' dynamic glycemic profiles in response to physiological and environmental stimuli better than the conventional point-in-time glucose quantification approaches. By analyzing glycemic patterns from CGM tracings, it may be possible to identify individuals at increased risk of developing diabetes. However, an important prerequisite is to establish the reliability and consistency of glucose response patterns captured by CGM under controlled conditions.

Participants will be given six different meals to examine the glucose responses to these meals. Two of these meals (white rice and an Ensure drink) will be given twice for each participant to investigate whether individuals have the same glucose response to the same meal given on different days. Glucose will be measured using continuous glucose monitors, that have a thin wire sensor that measures glucose under the skin every five minutes for up to 10 days.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Generally healthy

English speaking

Disqualifiers

Prior diagnosis of diabetes or taking medications that influence glucose metabolism, such as insulin, glucocorticoids, or Glucagon-like peptide-1 (GLP-1) receptor agonists.

Taking hydroxyurea medication

Taking beyond the maximum dose of acetaminophen (4g/day)

Known food allergies or severe sensitivities to any study materials (dairy or soy)

Trial design

Design model

Single group

Treatments tested in this trial

  • Six meal challenges

    Other intervention

    Two of the meal challenges will only be provided once: (1) a 20oz bottle of Mountain Dew (2) a "typical breakfast" that participants would eat normally. The other four challenges consist of two meal events that will each be repeated: (1) two 8-ounce bottles of Ensure® nutritional shake (2) one cup of microwaved white rice (microwaveable Minute brand Jasmine Rice cups). The rice challenge will be performed once with normal chewing and once by swallowing without chewing, while the Ensure challenge will be repeated the same way on both days.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Continuous glucose monitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Glycemic patterns from CGM

Beginning at baseline, a 4-hour incremental area under the glucose curve (iAUC) will be calculated using the trapezoidal method. Peak glucose will be defined as the maximum glucose excursion within the 4-hour window. Continuous glucose monitoring (CGM) CGM values are recorded every 5 minutes, so linear interpolation will be used to provide a CGM value every minute to line up with the ingestion time documented in the participant's log.

Time frame
baseline, every 4 hours for 6 days

Secondary outcomes

1

Fasting blood glucose levels

This outcome will be assessed from the CGM data recorded after a10 hour fast.

Time frame
baseline, daily for 6 days
2

Post prandial glucose levels

This outcome will be assessed from the CGM data recorded daily 4 hours after a study meal.

Time frame
baseline, daily for 6 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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