FGF21 and Fructose Challenge in Humans

Study Overview
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Brief Summary
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The primary aim of this study is to examine the effect of acute ingestion of fructose on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome.

Detailed Description
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Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to 10 different sweet beverages, separated by 2 weeks.

Official Title
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Fibroblast Growth Factor 21 and Fructose Challenge in Humans

Conditions
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Fasting

Intervention / Treatment
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* Dietary Supplement: oral carbohydrate challenge


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for lean subjects: Men and women ages 18-60 BMI 19-25 kg/m2; 19-23 for Asian subjects Stable weight (variation < 3 kg within 6 months of screening visit) Ability to give informed consent Ability to follow verbal and written instructions in English Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods) Specific exclusion criteria for lean subjects: Fasting blood glucose >100; 2 hr OGTT blood glucose >140 Fasting triglycerides >150 Inclusion criteria for metabolic syndrome subjects: 3 or more of the following (based on joint scientific statement by Alberti et al, 2009: Fasting triglycerides >150 mg/dl (or on treatment for elevated triglycerides) HDL cholesterol <40 mg/dl in men or <50 mg/dl in women Blood pressure > 130/85 (or antihypertensive treatment in a subject with history of hypertension) Fasting BG >100 Elevated waist circumference ** see below for race and ethnic specifications Men Women Asian or Central, South or Native American > 90 cm > 80 cm Non-Asian, Non-Latino United States > 102 cm > 88 cm General Exclusion criteria Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure) Uncontrolled hypertension (BP > 160/100 mmHg on or off antihypertensive medication) Marijuana or intravenous drug use Recent weight loss (> 3 kg within 6 months of the screening visit) Gastroparesis Inflammatory or irritable bowel disease Malignancy treated with chemotherapy within the past 3 years Depression or psychosis requiring hospitalization Renal insufficiency (creatinine clearance < 40 ml/min) Transaminases > 2x above the normal range Known liver disease Pregnancy within 6 months of the screening visit Lactation Failure to use medically approved contraceptive methods History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling) Change in dose of thyroid hormone or antithyroidal medication within 3 months of screening visit History of alcohol abuse within the past 5 years Fructose intolerance Exclusionary medications: Oral steroids Metformin Weight loss medications including nonprescription supplements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting (Healthy)<br>Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to10 different sweet beverages, separated by 2 weeks. | Dietary Supplement: oral carbohydrate challenge<br>* Participants will fast for 8 hours and then drink a beverage containing fructose.<br>|
| Experimental: Fasting (metabolic syndrome)<br>Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to10 different sweet beverages, separated by 2 weeks. | Dietary Supplement: oral carbohydrate challenge<br>* Participants will fast for 8 hours and then drink a beverage containing fructose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fibroblast Growth Factor 21 levels in human serum |  | 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FGF21, Fibroblast growth factor, fructose