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Recruiting NCT07209202

Fructose Intestinal Gluconeogenesis

No phase Interventional Healthy Participants Obese But Otherwise Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High fructose meal, Low fructose meal, 13C labeled fructose, oral, 13C labeled fructose, intravenous.
Who it may be relevant to
Registry conditions: Healthy Participants, Obese But Otherwise Healthy Participants. Basic parameters: 20 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Fructose Metabolism Effects on the Liver: Unraveling the Role of Defective Intestinal GNG in Individuals With Obesity

Overview

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.

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 six-hour fed tracer study will be initiated, during which participants will consume liquid meals containing stable isotopes at regular intervals and receive other isotopes intravenously. Meal composition will differ only by fructose content (High vs. Low) and tracer (oral vs. intravenous 13C-labeled fructose). Blood and urine samples will be collected frequently throughout the study. Each visit will be performed approximately three weeks apart. Vital signs and anthropometrics will be measured at each clinic visit.

Interventions

  • Other High fructose meal
    Liquid meals containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein.
  • Other Low fructose meal
    55% total carbohydrate (6% fructose), 30% fat, 15% protein.
  • Other 13C labeled fructose, oral
    Tracer amount of 13C labeled fructose administered orally in the meals.
  • Other 13C labeled fructose, intravenous
    Tracer amount of 13C fructose administered intravenously

Primary outcome measures

  • Fru-GNG [Time frame: 6 hours]
  • Fru-hGNG [Time frame: 6 hours]
  • Fru-iGNG [Time frame: 6 hours]
  • De novo lipogenesis (DNL) [Time frame: 6 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Touro University California — Vallejo

Identifiers

NCT: NCT07209202 · M-2624 · R01DK140477

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗