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Fructose: Substrate, Stimulus, or Both?

Primary Purpose

Insulin Resistance, Insulin Sensitivity, Pre Diabetes

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

High fructose, fructose labeled meal

High fructose, pyruvate labeled meal

Low fructose, fructose labeled meal

Low fructose, pyruvate labeled meal

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring Fructose, Glucose, Lipogenesis

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

Touro University CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

High fructose meal, with fructose label

High fructose meal, with pyruvate label

Low fructose meal, with fructose label

Low fructose meal, with pyruvate label

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Rate of appearance of UDP-glucose

An estimate of hepatic glycogen flux measured by administration of D1 galactose and acetaminophen

Rate of appearance of blood glucose from gluconeogenesis

Measured by the dilution method of labeled glucose

Secondary Outcome Measures

Serum triglyceride concentration

Fasting and postprandial serum triglyceride levels

Serum glucose concentration

Fasting and postprandial serum triglyceride levels

Serum lactate concentration

Fasting and postprandial serum lactate levels

Serum insulin concentration

Fasting and postprandial insulin levels

Serum free fatty acid concentration

Fasting and postprandial fatty acid levels

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.

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.

Extrasplanchnic fructose

Calculated using total plasma fructose, plasma 2-13C fructose enrichment, and endogenous fructose production

Whole body fructose oxidation

Measured by 13C atom % excess in exhaled breath, and VCO2 by indirect calorimetry

Full Information

NCT ID

NCT04168372

First Posted

November 14, 2019

Last Updated

April 25, 2022

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