Fructose Intestinal Gluconeogenesis
Recruiting · NCT07209202 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
13C labeled fructose, intravenous13C labeled fructose, oralHigh fructose mealLow fructose meal
What this trial is about
This study will test the hypothesis that within a defined range of fructose intake, the ability to convert fructose to glucose (via gluconeogenesis) in the small intestine plays a protective role for the liver, shielding it from the deleterious effects of fructose. We will investigate whether this protective effect of the intestine is impaired in individuals with obesity.
Who can take part
Age range
20 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- BMI 30 to 38 kg/m2 (obese group) or BMI 19 to 25 kg/m2 (lean group)
Exclusion criteria
- Pregnancy or lactation within the past six months;
- Type 1 or 2 diabetes mellitus (including fasting glucose ≥126 mg/dL, HgbA1c ≥6.5%);
- History of liver disease or AST and ALT 2x above the upper limit of normal;
- Fasting triglyceride \> 300 mg/dl; total cholesterol levels above the 95th percentile for age and sex;
- Hemoglobin (Hgb) \<12.5g/d or hematocrit\<3x Hgb value;
- Report of HIV or hepatitis B or C infection;
- History of cancer, other than basal cell or squamous cell carcinoma or kidney disease stage 3 or higher or patients currently on dialysis;
- Use of any anti-diabetic medications or hypolipidemic agents in the past six months;
- History of surgical procedure for obesity;
- Change in body weight \>5% in the past six months (by self-report);
- History of other conditions known to affect insulin sensitivity and lipid metabolism (e.g., polycystic ovary syndrome), history of galactosemia, hereditary fructose intolerance, or who test positive for fructose malabsorption at screening;
- Known intolerance to acetaminophen.
Where it is running
1 location listed across 1 US state.
- Touro University California - Vallejo, California, United States