Daily Blood Glucose Trends in Patients at Risk for Diabetes

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06000735
Study type	Interventional
Source	University of California, Los Angeles
Contact	Karol Watson, MD, PhD
Phone	310-825-9011
Email	kwatson@mednet.ucla.edu
Status	Not yet recruiting
Phase	N/A
Start date	October 1, 2023
Completion date	October 30, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.