FGF21 and Fructose Challenge in Humans

Fibroblast Growth Factor 21 and Fructose Challenge in Humans

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.

Study Overview

• Status: Completed
• Conditions: Fasting
• Intervention / Treatment: Dietary supplement: oral carbohydrate challenge

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasting (Healthy); 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; Participants will fast for 8 hours and then drink a beverage containing fructose.
Experimental: Fasting (metabolic syndrome); 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; Participants will fast for 8 hours and then drink a beverage containing fructose.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimated): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: fructose; FGF21; Fibroblast growth factor
• Other Study ID Numbers: 2015P000381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO