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FGF21 and Fructose Challenge in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02884791
Recruitment Status : Active, not recruiting
First Posted : August 31, 2016
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Jody Dushay, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Fasting Dietary Supplement: oral carbohydrate challenge Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Fibroblast Growth Factor 21 and Fructose Challenge in Humans
Study Start Date : February 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

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.




Primary Outcome Measures :
  1. Change in Fibroblast Growth Factor 21 levels in human serum [ Time Frame: 5 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884791


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Responsible Party: Jody Dushay, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02884791    
Other Study ID Numbers: 2015P000381
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jody Dushay, Beth Israel Deaconess Medical Center:
FGF21
Fibroblast growth factor
fructose