Glucose Metabolism DisordersNCT05845827
Dietary Impact on Continuous Glucose Monitoring
An observational study of Glucose Metabolism Disorders and Dietary Habits, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Cardiorespiratory fitness (CRF), also known as "exercise capacity", is the capacity of respiratory and circulatory systems to supply oxygen to skeletal muscle during exercise for the generation of energy. Read more about this study
- Who is it for?
- Ages 14 to 22 years
- Conditions the study is for
- Glucose Metabolism Disorders, Dietary Habits, Pediatric ALL
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 22 years
- All sexes
- Child, Adult
Study population: Adolescents and young adults, ages 14-22 years
Who may be able to join
- Adolescents and young adults, ages 14-22 years
Who cannot join
- Previous diagnosis of type 1 or 2 diabetes
- Previous diagnosis of hyperlipidemia or other metabolic disease
- Use of medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin).
- Allergies to milk.
- Inability to participant in the maximal exercise test on the treadmill.
- Individuals not having android or IOS phones
- Individuals who cannot speak and/or write in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Impact of Dietary Intake on Continuous Glucose Patterns Considering Cardiorespiratory Fitness Levels.
Cardiorespiratory fitness (CRF), also known as "exercise capacity", is the capacity of respiratory and circulatory systems to supply oxygen to skeletal muscle during exercise for the generation of energy. Determinants of CRF include lung capacity, capillary density, cardiac output, hemoglobin concentration, and mitochondrial function. The research group studies how CRF is related to fuel utilization, yielding a mechanistic understanding of the association between lower CRF and worsening metabolic health via mitochondrial function. The objective of this study is to measure fuel utilization in response to habitual diet for one week in adolescents and young adults, ages 14-22 years (n=30). Fuel utilization will be estimated by glucose measures using a continuous glucose monitor (CGM). Habitual dietary intake will be collected via a mobile phone application (BiteAI, Inc) that uses artificial intelligence to extract nutrient information from food photographs. Participants will undergo two standard of care (SOC) meal tolerance tests at home - a glucose tolerance test and a Ensure® mixed meal tolerance test. CRF will be estimated by measuring maximum oxygen consumption (VO2 max) during a graded treadmill test. The hypothesis is that a higher VO2 max will be associated with increased fuel utilization, measured by lower glucose response to the SOC meal tolerance tests. The proposed study is described in the following aims:
SPECIFIC AIM 1. Test for feasibility of completion of self-report dietary food records, completion of two at home meal tolerance tests that are standard of care for metabolic health screening, and completion of a seven-day continuous glucose monitor.
Read more
SPECIFIC AIM 2. Identify nutrients and foods that are associated with an elevated glucose response.
SPECIFIC AIM 3. Assess the influence of VO2 max on the glucose response to the SOC glucose tolerance test and Ensure® mixed meal tolerance test.
- Conditions
- Glucose Metabolism Disorders, Dietary Habits, Pediatric ALL, Adult ALL
- Medical subject headings
- Glucose Metabolism Disorders, Feeding Behavior, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dietary records completed by each study participant
The researchers will measure dietary intake using a mobile phone application called BiteSnap. The goal is to have participants report >90% of their meals using mobile phone photos to extract nutrient information.
Measured: 7-10 days
Number of days wearing the continuous glucose monitor
The researchers will measure the amount of time each participant wears the continuous glucose monitor. The goal is to have participants wear the monitor for >90% of the time in the study.
Measured: 7-10 days
Completion of the at-home glucose tolerance test
Participants will be asked to drink a 75-gram glucose tolerance test. The researchers will measure the number of participants that self-reported drinking the shake at fasting. The goal will be 90% of participants self-report drinking the shake at fasting.
Measured: 7-10 days
Secondary outcomes (2)
Identify nutrients associated with an elevated glucose response, measured by the continuous glucose monitor.
Participants will track the foods they eat while wearing the Dexcom continuous glucose monitors. Researchers will identify specific foods that are associated with increases in glucose response, considering associations across the group and associations within each individual.
Measured: 7-10 days
Access the relationship between fitness levels and glucose response to standard of care meal tests.
Researchers will assess the association between fitness levels and glucose levels at 60 and 120 minutes after the at-home standard of care meal tests. Fitness levels are measured using a VO2 max test.
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start20 Jun 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer L. Meijer, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845827
- Sponsor's protocol ID
- STUDY02001962
- Status last verified
- Feb 2024
- First submitted
- 14 Apr 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ge M, Lebby SR, Chowkwale S, Harrison C, Palmer GM, Loud KJ, Gilbert-Diamond D, Vajravelu ME, Meijer JL. Impact of Dietary Intake and Cardiorespiratory Fitness on Glycemic Variability in Adolescents: An Observational Study. Curr Dev Nutr. 2025 Jan 21;9(2):104547. doi: 10.1016/j.cdnut.2025.104547. eCollection 2025 Feb.
PubMed 39996052
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Intake on Continuous Glucose Patterns Considering Cardiorespiratory Fitness Levels.
- ClinicalTrials.gov ID
- NCT05845827
- Acronym / sponsor ID
- STUDY02001962
- Conditions
- Glucose Metabolism Disorders, Dietary Habits, Pediatric ALL, Adult ALL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiorespiratory fitness (CRF), also known as "exercise capacity", is the capacity of respiratory and circulatory systems to supply oxygen to skeletal muscle during exercise for the generation of energy. Determinants of CRF include lung capacity, capillary density, cardiac output, hemoglobin concentration, and mitochondrial function. The research group studies how CRF is related to fuel utilization, yielding a mechanistic understanding of the association between lower CRF and worsening metabolic health via mitochondrial function. The objective of this study is to measure fuel utilization in response to habitual diet for one week in adolescents and young adults, ages 14-22 years (n=30). Fuel utilization will be estimated by glucose measures using a continuous glucose monitor (CGM). Habitual dietary intake will be collected via a mobile phone application (BiteAI, Inc) that uses artificial intelligence to extract nutrient information from food photographs. Participants will undergo two standard of care (SOC) meal tolerance tests at home - a glucose tolerance test and a Ensure® mixed meal tolerance test. CRF will be estimated by measuring maximum oxygen consumption (VO2 max) during a graded treadmill test. The hypothesis is that a higher VO2 max will be associated with increased fuel utilization, measured by lower glucose response to the SOC meal tolerance tests. The proposed study is described in the following aims:
SPECIFIC AIM 1. Test for feasibility of completion of self-report dietary food records, completion of two at home meal tolerance tests that are standard of care for metabolic health screening, and completion of a seven-day continuous glucose monitor.
SPECIFIC AIM 2. Identify nutrients and foods that are associated with an elevated glucose response.
SPECIFIC AIM 3. Assess the influence of VO2 max on the glucose response to the SOC glucose tolerance test and Ensure® mixed meal tolerance test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Adolescents and young adults, ages 14-22 years
Key inclusion criteria (1 listed)
- Adolescents and young adults, ages 14-22 years
Key exclusion criteria (7 listed)
- Previous diagnosis of type 1 or 2 diabetes
- Previous diagnosis of hyperlipidemia or other metabolic disease
- Use of medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin).
- Allergies to milk.
- Inability to participant in the maximal exercise test on the treadmill.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of dietary records completed by each study participant
Time frame: 7-10 days
The researchers will measure dietary intake using a mobile phone application called BiteSnap. The goal is to have participants report >90% of their meals using mobile phone photos to extract nutrient information.
Number of days wearing the continuous glucose monitor
Time frame: 7-10 days
The researchers will measure the amount of time each participant wears the continuous glucose monitor. The goal is to have participants wear the monitor for >90% of the time in the study.
Completion of the at-home glucose tolerance test
Time frame: 7-10 days
Participants will be asked to drink a 75-gram glucose tolerance test. The researchers will measure the number of participants that self-reported drinking the shake at fasting. The goal will be 90% of participants self-report drinking the shake at fasting.
2 secondary outcomes
Identify nutrients associated with an elevated glucose response, measured by the continuous glucose monitor.
Time frame: 7-10 days
Access the relationship between fitness levels and glucose response to standard of care meal tests.
Time frame: 7-10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 39996052Ge M, Lebby SR, Chowkwale S, Harrison C, Palmer GM, Loud KJ, Gilbert-Diamond D, Vajravelu ME, Meijer JL. Impact of Dietary Intake and Cardiorespiratory Fitness on Glycemic Variability in Adolescents: An Observational Study. Curr Dev Nutr. 2025 Jan 21;9(2):104547. doi: 10.1016/j.cdnut.2025.104547. eCollection 2025 Feb.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Metabolism Disorders and Dietary Habits, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dietary records completed by each study participant (time frame: 7-10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05845827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024; AzTrials last refreshed its copy on 26 Oct 2026.