FGF21 and Fructose Challenge in Humans

NCT02884791 | Completed

• 1 other identifier: 2015P000381
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasting

Keywords

FGF21; Fibroblast growth factor; fructose

Outcome Measures

Primary Outcomes (1)

• Change in Fibroblast Growth Factor 21 levels in human serum

  5 hours

Study Arms (2)

Fasting (Healthy)

EXPERIMENTAL

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

Fasting (metabolic syndrome)

EXPERIMENTAL

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

Interventions

oral carbohydrate challenge DIETARY_SUPPLEMENT

Participants will fast for 8 hours and then drink a beverage containing fructose.

Fasting (Healthy); Fasting (metabolic syndrome)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Fasting blood glucose \>100; 2 hr OGTT blood glucose \>140
• Fasting triglycerides \>150
• 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
• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: August 31, 2016
• Study Start: February 1, 2016
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)