Fructose: Substrate, Stimulus, or Both?

Touro University, California

Status: Completed

Conditions: Insulin Resistance; Pre Diabetes; Insulin Sensitivity

Treatments: Other: High fructose, fructose labeled meal; Other: Low fructose, fructose labeled meal; Other: High fructose, pyruvate labeled meal; Other: Low fructose, pyruvate labeled meal

Study type: Interventional

Funder types: Other

Identifiers

NCT04168372

M-3018

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

35 participants in 4 patient groups

High fructose meal, with fructose label

Experimental group

Description:

2-13C fructose incorporated into a meal with high fructose content

Treatment:

Other: High fructose, fructose labeled meal

High fructose meal, with pyruvate label

Experimental group

Description:

2-13C pyruvate incorporated into a meal with high fructose content

Treatment:

Other: High fructose, pyruvate labeled meal

Low fructose meal, with fructose label

Experimental group

Description:

2-13C fructose incorporated into a meal with low fructose content

Treatment:

Other: Low fructose, fructose labeled meal

Low fructose meal, with pyruvate label

Experimental group

Description:

2-13C pyruvate incorporated into a meal with low fructose content

Treatment:

Other: Low fructose, pyruvate labeled meal