Status:
NOT_YET_RECRUITING
Fructose Intestinal Gluconeogenesis
Lead Sponsor:
Touro University, California
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Participants
Obese But Otherwise Healthy Participants
Eligibility:
All Genders
20-55 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Qualified participants will undergo a sugar tolerance test at baseline and then randomized to undergo four separate outpatient tracer/feeding studies in a crossover fashion. After an overnight fast, a...
Eligibility Criteria
Inclusion
- BMI 30 to 38 kg/m2 (obese group) or BMI 19 to 25 kg/m2 (lean group)
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07209202
Start Date
December 1 2025
End Date
June 1 2030
Last Update
October 6 2025
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