Fructose: Substrate, Stimulus, or Both?

Insulin Resistance Clinical Trial

Official title:

Fructose: Substrate, Stimulus, or Both?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04168372
• Other study ID #: M-3018
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Touro University, California
• Contact: Sally Chiu, PhD
• Phone: 707-638-5404
• Email: sally.chiu[@]tu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Pre Diabetes
• Prediabetic State

Intervention

Other:
• High fructose, fructose labeled meal
Liquid meal containing high fructose (16% of energy), labeled with 2-13C fructose
• High fructose, pyruvate labeled meal
Liquid meal containing high fructose (16% of energy), labeled with 2-13C pyruvate
• Low fructose, fructose labeled meal
Liquid meals containing low fructose (6% of energy), labeled with 2-13C fructose
• Low fructose, pyruvate labeled meal
Liquid meal containing low fructose (6% of energy), labeled with 2-13C pyruvate

Locations

Country	Name	City	State
United States	Touro University California	Vallejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Touro University, California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic fractional de novo lipogenesis in triglyceride rich lipoprotein (TRL)	Measured by the detection of 13C carbons in TRL-palmitate from administered 13C labeled pyruvate or 13C labeled fructose.	6 hours
Primary	Rate of appearance of UDP-glucose	An estimate of hepatic glycogen flux measured by administration of D1 galactose and acetaminophen	6 hours
Primary	Rate of appearance of blood glucose from gluconeogenesis	Measured by the dilution method of labeled glucose	6 hours
Secondary	Serum triglyceride concentration	Fasting and postprandial serum triglyceride levels	6 hours
Secondary	Serum glucose concentration	Fasting and postprandial serum triglyceride levels	6 hours
Secondary	Serum lactate concentration	Fasting and postprandial serum lactate levels	6 hours
Secondary	Serum insulin concentration	Fasting and postprandial insulin levels	6 hours
Secondary	Serum free fatty acid concentration	Fasting and postprandial fatty acid levels	6 hours
Secondary	Enteral (chylomicron) fractional de novo lipogenesis (DNL)	Measured by the detection of 13C carbons in chylomicron-palmitate from administered 13C labeled pyruvate or 13C labeled fructose.	6 hours
Secondary	Hepatic (VLDL) fractional de novo lipogenesis (DNL)	Measured by the detection of 13C carbons in VLDL-palmitate from administered 13C labeled pyruvate or 13C labeled fructose.	6 hours
Secondary	Extrasplanchnic fructose	Calculated using total plasma fructose, plasma 2-13C fructose enrichment, and endogenous fructose production	6 hours
Secondary	Whole body fructose oxidation	Measured by 13C atom % excess in exhaled breath, and VCO2 by indirect calorimetry	6 hours