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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.
Conditions:
🦠 Stress 🦠 Blood Sugar; High 🦠 Cholesterol, Elevated 🦠 Diet Habit
🗓️ Study Start (Actual) 1 October 2023
🗓️ Primary Completion (Estimated) 30 October 2024
✅ Study Completion (Estimated) 30 October 2024
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 August 2023
  • First Submitted that Met QC Criteria 14 August 2023
  • First Posted 21 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 August 2023
  • Last Update Posted 21 August 2023
  • Last Verified August 2023
I'm interested ...!!