Daily Blood Glucose Trends in Patients at Risk for Diabetes

NCT06000735 | Unknown FDA Device

• 1 other identifier: 21-000975
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Blood Sugar; High; Cholesterol, Elevated; Diet Habit

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2

EXPERIMENTAL

All participants will go through the same intervention described above.

Device: 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2

Interventions

7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2 DEVICE

All participants will go through the same intervention described above

7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karol E. Watson, MD: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

UCLA Clinical Nutrition Clinic, 200 UCLA Medical Plaza, Suite 365-C

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Hypercholesterolemia; Feeding Behavior

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Karol Watson, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karol Watson, MD, PhD

CONTACT

310-825-9011; kwatson@mednet.ucla.edu

Vijaya Surampudi, MD

CONTACT

310-825-7921; vsurampudi@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, Cardiology

Model Details: Pilot Study (uncontrolled)

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: October 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)