Daily Blood Glucose Trends in Patients at Risk for Diabetes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Diet Habit; Cholesterol, Elevated; Blood Sugar; High
• Intervention / Treatment: Device: 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karol Watson, MD, PhD; Phone Number: 310-825-9011; Email: kwatson@mednet.ucla.edu
• Study Contact Backup: Name: Vijaya Surampudi, MD; Phone Number: 310-825-7921; Email: vsurampudi@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Clinical Nutrition Clinic, 200 UCLA Medical Plaza, Suite 365-C
      • Contact: Vijaya Surampudi, MD; Phone Number: 310-825-7921; Email: vsurampudi@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2; All participants will go through the same intervention described above.	Device: 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2; All participants will go through the same intervention described above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Collaborators and Investigators

• Sponsor: Karol E. Watson, MD
• Collaborators: University of California, Los Angeles
• Investigators: Principal Investigator: Karol Watson, MD, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hyperglycemia; Hypercholesterolemia
• Other Study ID Numbers: 21-000975

Drug and device information, study documents

• 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