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Lifestyle Patterns and Glycemic Control
The goal of the proposed study is to evaluate the feasibility and initial efficacy of stabilizing lifestyle behaviors to improve glucose control and body composition in patients with pre-diabetes. The investigator proposes that following stable lifestyle behaviors will improve patients' glucose control, body composition, and liver fat. The results from this study has the potential to impact clinical practice and patient care.
Conditions:
🦠 Pre-diabetes
🗓️ Study Start (Actual) 19 January 2022
🗓️ Primary Completion (Estimated) 1 June 2025
✅ Study Completion (Estimated) 1 June 2025
👥 Enrollment (Estimated) 34
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Pre-diabetic kg/m2 (hemoglobin A1c 5.7-6.9%)
    • * 25 years or older
    • * BMI between 25-39.9 kg/m2
    • * Sleep duration ≥6 hours a night assessed with wrist actigraphy (for 14 nights)
    • * Variable bedtime, SD≥45 minutes.

    Exclusion Criteria:

    • * Chronic Kidney Disease (GFR\<60)
    • * Uncontrolled hypertension (≥160/100 mmHg)
    • * Obstructive Sleep Apnea
    • * Psychiatric or neurological disorder
    • * Prevalent cardiovascular disease
    • * Dyslipidemia (triglycerides≥200 mg/dL)
    • * Medications that affect insulin sensitivity, glucose concentrations, and body weight
    • * Non-day or rotating shift workers
    • * Travel across time zones
    • * Active participation in weight loss program or within past 3 months
    • * Current or past alcohol/drug abuse
Ages Eligible for Study: 25 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 25 January 2022
  • First Submitted that Met QC Criteria 25 January 2022
  • First Posted 4 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 July 2024
  • Last Update Posted 26 July 2024
  • Last Verified July 2024
I'm interested ...!!