Clinical trial NCT06000735: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Blood Sugar; High
Cholesterol, Elevated
Diet Habit
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2023-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot Study (uncontrolled)
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Blood glucose time-in-range (TIR)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Clinical Nutrition Clinic, 200 UCLA Medical Plaza, Suite 365-C
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Karol Watson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: