StressNCT06000735
Daily Blood Glucose Trends in Patients at Risk for Diabetes
A study testing 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2 in people with Stress and Blood Sugar; High, run by Karol E. Watson, MD at 1 site in United States.
Trial summary
The goal of this study is to learn about the relationship between blood sugar, diet, stress, and metabolic parameters including waist circumference, body mass index (BMI), cholesterol levels and blood pressure in patients at risk for diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Blood Sugar; High, Cholesterol, Elevated
- What is being tested?
- 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Oct 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Any subject currently taking blood thinning medications such as Warfarin or Coumadin
- Any history of gastrointestinal disease or surgery except for appendectomy or cholecystectomy.
- History of gastrointestinal surgery, diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP >160mmHg, diastolic BP >95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history.
- Pregnant or breastfeeding
- Currently uses tobacco products.
- Currently has an alcohol intake > 20 g ⁄ day;
- Currently has a coffee intake > 3 cups ⁄ day;
- Is unable or unwilling to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Clinical Nutrition Clinic, 200 UCLA Medical Plaza, Suite 365-C
Los Angeles, California, 90095
Vijaya Surampudi, MD, 310-825-7921, vsurampudi@mednet.ucla.edu
About this study
The goal of this study is to learn about the relationship between blood sugar, diet, stress, and metabolic parameters including waist circumference, body mass index (BMI), cholesterol levels and blood pressure in patients at risk for diabetes. The main questions it aims to answer are 1) are there trends in blood sugar responses after meals for patients at risk of developing diabetes? And 2) are there correlations between stress and fluctuations in blood sugar? During the first visit, participant's waist circumference, body composition, cholesterol, and resting blood pressure will be measured, and a continuous glucose monitor sensor will be placed on the participant's non-dominant arm. This sensor will be worn for seven days, and the participant will be asked to complete a daily food log during that time. Each participant will be asked to return to clinic after one week to return the continuous glucose monitor and daily food log.
Read the detailed description
The relevance of diet, sleep, and stress and their metabolic consequences in cardiovascular risk is principal. Current improvements and developments in food labeling and personal self-tracking devices and applications (e.g. continuous glucose monitors [CGMs] and food logging apps), signal potential for better quantification of personal traits that could assist in defining personalized approaches for glycemic control. The objective of the proposed study is to evaluate daily glucose fluctuations and blood glucose time-in-range in relation to dietary intake and correlate excursions with metabolic risk factors in non-diabetic adults with one risk factor for diabetes mellitus. With the use of CGM technology to explore daily blood glucose trends in patients at risk for diabetes, the goal is to investigate relationships between blood glucose and metabolic parameters as well as sleep and stress factors.
The study will include two visits. During the first visit, the patient is explained the study details, their consent is obtained, their metabolic parameters measured, perceived stress scale questionnaire administered, and finally, the CGM is placed on them. The patient will be asked to return after one week to return the CGM reader, so the study team may collect the data.
- Conditions
- Stress, Blood Sugar; High, Cholesterol, Elevated, Diet Habit
- Being tested
- 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2
- Medical subject headings
- Hyperglycemia, Hypercholesterolemia, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2Device
All participants will go through the same intervention described above
| Study group | Role | What they receive |
|---|---|---|
| 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2 | Experimental | All participants will go through the same intervention described above. Receives: Device: 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose time-in-range (TIR)
The relationship between participants' TIR and cholesterol level, blood pressure, waist circumference, and perceived stress levels will be analyzed for any correlations.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot Study (uncontrolled)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karol E. Watson, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor-investigator, Karol E. Watson, MD, University of California, Los Angeles
- Investigators
- Karol Watson, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000735
- Sponsor's protocol ID
- 21-000975
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Blood Glucose Trends in Patients at Risk for Diabetes
- ClinicalTrials.gov ID
- NCT06000735
- Acronym / sponsor ID
- 21-000975
- Conditions
- Stress, Blood Sugar; High, Cholesterol, Elevated, Diet Habit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Karol E. Watson, MDUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 21 Aug 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.
The goal of this study is to learn about the relationship between blood sugar, diet, stress, and metabolic parameters including waist circumference, body mass index (BMI), cholesterol levels and blood pressure in patients at risk for diabetes. The main questions it aims to answer are 1) are there trends in blood sugar responses after meals for patients at risk of developing diabetes? And 2) are there correlations between stress and fluctuations in blood sugar? During the first visit, participant's waist circumference, body composition, cholesterol, and resting blood pressure will be measured, and a continuous glucose monitor sensor will be placed on the participant's non-dominant arm. This sensor will be worn for seven days, and the participant will be asked to complete a daily food log during that time. Each participant will be asked to return to clinic after one week to return the continuous glucose monitor and daily food log.
Detailed description
The relevance of diet, sleep, and stress and their metabolic consequences in cardiovascular risk is principal. Current improvements and developments in food labeling and personal self-tracking devices and applications (e.g. continuous glucose monitors [CGMs] and food logging apps), signal potential for better quantification of personal traits that could assist in defining personalized approaches for glycemic control. The objective of the proposed study is to evaluate daily glucose fluctuations and blood glucose time-in-range in relation to dietary intake and correlate excursions with metabolic risk factors in non-diabetic adults with one risk factor for diabetes mellitus. With the use of CGM technology to explore daily blood glucose trends in patients at risk for diabetes, the goal is to investigate relationships between blood glucose and metabolic parameters as well as sleep and stress factors.
The study will include two visits. During the first visit, the patient is explained the study details, their consent is obtained, their metabolic parameters measured, perceived stress scale questionnaire administered, and finally, the CGM is placed on them. The patient will be asked to return after one week to return the CGM reader, so the study team may collect the data.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot Study (uncontrolled)
| Arm | Type | Receives |
|---|---|---|
| 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2 | Experimental | Device: 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2All participants will go through the same intervention described above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Any subject currently taking blood thinning medications such as Warfarin or Coumadin
- Any history of gastrointestinal disease or surgery except for appendectomy or cholecystectomy.
- History of gastrointestinal surgery, diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP >160mmHg, diastolic BP >95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history.
- Pregnant or breastfeeding
- Currently uses tobacco products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2All participants will go through the same intervention described above | Device | 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2 |
Primary outcome
Blood glucose time-in-range (TIR)
Time frame: 7 days
The relationship between participants' TIR and cholesterol level, blood pressure, waist circumference, and perceived stress levels will be analyzed for any correlations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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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.
Karol Watson, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2 in people with Stress and Blood Sugar; High, run by Karol E. Watson, MD 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 0 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karol Watson, MD, PhD (310-825-9011, kwatson@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose time-in-range (TIR) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.