Fructose: Substrate, Stimulus, or Both?
This objective of this study is to use sensitive methodology under controlled conditions to investigate the mechanisms by which fructose consumption contributes to excess fatty acid synthesis and elevations in blood glucose levels following consumption of meals containing fructose.
Conditions:
๐Ÿฆ  Insulin Resistance ๐Ÿฆ  Insulin Sensitivity ๐Ÿฆ  Pre Diabetes
๐Ÿ—“๏ธ Study Start (Actual) 15 September 2019
๐Ÿ—“๏ธ Primary Completion (Estimated) 1 June 2024
โœ… Study Completion (Estimated) 30 December 2024
๐Ÿ‘ฅ Enrollment (Estimated) 36
๐Ÿ”ฌ Study Type INTERVENTIONAL
๐Ÿ“Š Phase NA
Locations:
๐Ÿ“ Vallejo, California, United States

๐Ÿ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

    • * Body Mass Index 22 to 35 kg/m2
    • * Prediabetic (HbA1c 5.7% to 6.5%) or hyperinsulinemic (fasting insulin โ‰ฅ12 ยตIU/mL) but non-diabetic (fasting glucose \<126mg/dL and HbA1c \< 6.5%) ; or normal control (fasting insulin \<10 ยตIU/mL, fasting glucose \<100 mg/dL, and HbA1c \< 5.7%)

    Exclusion Criteria:

    • * Pregnancy or lactation within the past six months
    • * Type 1 or 2 diabetes mellitus
    • * History of liver disease or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2x the upper limit of normal (ULN);
    • * Fasting triglyceride or total cholesterol levels above 95th percentile for age and sex;
    • * Hemoglobin or hematocrit below the lower limit of normal for sex;
    • * Report of hepatitis or HIV infection;
    • * History of cancer, use of any anti-diabetic medications or hypolipidemic agents in the past six months;
    • * History of surgical procedure for obesity;
    • * Self-reported change in body weight \>5% in the past six months;
    • * History of other conditions known to affect insulin sensitivity and lipid metabolism;
    • * Known intolerance to acetaminophen or components of the liquid test meals.
Ages Eligible for Study: 20 Years to 55 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

๐Ÿ—“๏ธ 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 November 2019
  • First Submitted that Met QC Criteria 15 November 2019
  • First Posted 19 November 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 November 2023
  • Last Update Posted 22 November 2023
  • Last Verified November 2023