Clinical trial NCT02884791: FGF21 and Fructose Challenge in Humans
Official title: Fibroblast Growth Factor 21 and Fructose Challenge in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Keywords: FGF21
Fibroblast growth factor
fructose
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Fibroblast Growth Factor 21 levels in human serum
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: