Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2019-09-15
2024-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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High fructose meal, with fructose label
2-13C fructose incorporated into a meal with high fructose content
High fructose, fructose labeled meal
Liquid meal containing high fructose (16% of energy), labeled with 2-13C fructose
High fructose meal, with pyruvate label
2-13C pyruvate incorporated into a meal with high fructose content
High fructose, pyruvate labeled meal
Liquid meal containing high fructose (16% of energy), labeled with 2-13C pyruvate
Low fructose meal, with fructose label
2-13C fructose incorporated into a meal with low fructose content
Low fructose, fructose labeled meal
Liquid meals containing low fructose (6% of energy), labeled with 2-13C fructose
Low fructose meal, with pyruvate label
2-13C pyruvate incorporated into a meal with low fructose content
Low fructose, pyruvate labeled meal
Liquid meal containing low fructose (6% of energy), labeled with 2-13C pyruvate
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
55 Years
ALL
Yes
Sponsors
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Touro University, California
OTHER
Responsible Party
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Principal Investigators
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Jean-Marc Schwarz, PhD
Role: PRINCIPAL_INVESTIGATOR
Touro University, California
Locations
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Touro University California
Vallejo, California, United States
Countries
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Other Identifiers
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M-3018
Identifier Type: -
Identifier Source: org_study_id
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