Back to resultsDaily Blood Glucose Trends in Patients at Risk for Diabetes
Primary Purpose
Stress, Blood Sugar; High, Cholesterol, Elevated
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2
Sponsored by
About this trial
This is an interventional prevention trial for Stress
Eligibility Criteria
Inclusion Criteria (Must meet at least one of the following): Overweight and/or obese BMI classification, 25 to 35 kg/m2 Fasting serum glucose ≥100 mg/dL and <126 mg/dL or HbA1c >5.7% and < 6.5% Family history of Type 2 DM History of hypertension, hypertriglyceridemia, heart disease, and/or stroke History of gestational diabetes Exclusion Criteria: 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.
Sites / Locations
- UCLA Clinical Nutrition Clinic, 200 UCLA Medical Plaza, Suite 365-C
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2
Arm Description
All participants will go through the same intervention described above.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06000735
First Posted
August 14, 2023
Last Updated
August 14, 2023
Sponsor
Karol E. Watson, MD
Collaborators
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT06000735
Brief Title
Daily Blood Glucose Trends in Patients at Risk for Diabetes
Official Title
Daily Blood Glucose Trends in Patients at Risk for Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karol E. Watson, MD
Collaborators
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Blood Sugar; High, Cholesterol, Elevated, Diet Habit
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot Study (uncontrolled)
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2
Arm Type
Experimental
Arm Description
All participants will go through the same intervention described above.
Intervention Type
Device
Intervention Name(s)
7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2
Intervention Description
All participants will go through the same intervention described above
Primary Outcome Measure Information:
Title
Blood glucose time-in-range (TIR)
Description
The relationship between participants' TIR and cholesterol level, blood pressure, waist circumference, and perceived stress levels will be analyzed for any correlations.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Must meet at least one of the following):
Overweight and/or obese BMI classification, 25 to 35 kg/m2
Fasting serum glucose ≥100 mg/dL and <126 mg/dL or HbA1c >5.7% and < 6.5%
Family history of Type 2 DM
History of hypertension, hypertriglyceridemia, heart disease, and/or stroke
History of gestational diabetes
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karol Watson, MD, PhD
Phone
310-825-9011
Email
kwatson@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Vijaya Surampudi, MD
Phone
310-825-7921
Email
vsurampudi@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karol Watson, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Clinical Nutrition Clinic, 200 UCLA Medical Plaza, Suite 365-C
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijaya Surampudi, MD
Phone
310-825-7921
Email
vsurampudi@mednet.ucla.edu
12. IPD Sharing Statement
Learn more about this trial
Daily Blood Glucose Trends in Patients at Risk for Diabetes
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