Fructose: Substrate, Stimulus, or Both? (NCT04168372) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Fructose: Substrate, Stimulus, or Both?
United States35 participantsStarted 2019-09-15
Plain-language summary
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.
Who can participate
Age range
20 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body Mass Index 22 to 35 kg/m2
* Prediabetic (HbA1c 5.7% to 6.5%) or hyperinsulinemic (fasting insulin ≥12 µIU/mL) but non-diabetic (fasting glucose \<126mg/dL and HbA1c \< 6.5%) ; or normal control (fasting insulin \<10 µIU/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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hepatic fractional de novo lipogenesis in triglyceride rich lipoprotein (TRL)
Timeframe: 6 hours
2
Rate of appearance of UDP-glucose
Timeframe: 6 hours
3
Rate of appearance of blood glucose from gluconeogenesis