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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04168372
Other study ID # M-3018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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