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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02884791
Other study ID # 2015P000381
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date May 30, 2023

Study information

Verified date August 2023
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
oral carbohydrate challenge
Participants will fast for 8 hours and then drink a beverage containing fructose.

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Fibroblast Growth Factor 21 levels in human serum 5 hours
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