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Fructose Intestinal Gluconeogenesis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
20 Years to 55 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Blood and urine samples will be collected frequently throughout the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the small intestine protects the liver by turning fructose, a type of sugar, into glucose, another sugar. It will compare people with and without obesity to see if this protection is weaker in people with obesity.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a BMI of 30 to 38 for the group with obesity, or 19 to 25 for the lean group. BMI is a measure of weight compared with height.

Who can't join

  • Pregnancy or breastfeeding within the past 6 months.
  • Type 1 or type 2 diabetes, including fasting blood sugar of 126 mg/dL or higher or A1c of 6.5% or higher. A1c measures average blood sugar. Also excluded: use of diabetes or blood-fat-lowering medicines in the past 6 months.
  • Past liver disease, or liver blood tests called AST and ALT at twice the highest normal level; reported HIV or hepatitis B or C infection.
  • Fasting triglycerides (a blood fat) above 300 mg/dL, or total cholesterol higher than that of 95% of people of the same age and sex.
  • Low hemoglobin, which carries oxygen in blood (below 12.5), or hematocrit, the share of blood made up of red blood cells, below 3 times the hemoglobin value.
  • Past cancer, except basal cell or squamous cell skin cancer; stage 3 or worse kidney disease; or current dialysis, a treatment that filters blood.
  • Past weight-loss surgery, or a reported weight change of more than 5% in the past 6 months.
  • Conditions that affect how the body responds to insulin or handles fats, such as polycystic ovary syndrome; galactosemia or inherited fructose intolerance, which affect how the body handles certain sugars; a positive screening test for trouble absorbing fructose; or known intolerance to acetaminophen.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CA